Prospective Representative National Survey of Body Mass Index in People With Spinal Cord Injury.
Conditions: Spinal Cord Injuries
Sponsor: Rigshospitalet, Denmark

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Study protocol Version: 1.0 date:04.12.17 
Health promotion and cardiovascular risk reduction among people with spinal cord injury: 
physical activity, healthy diet and maintaineance after discharge. 
(Sub study 1: Prospective Survey of Body Mass Index in People With Spinal Cord Injury) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study protocol Version: 1.0 dato:04.12.17 
Health promotion and cardiovascular risk reduction among people with spinal cord injury: 
physical activity, healthy diet and maintaineance after discharge. 
Background The incidence of a Spinal Cord Injury in Denmark is 10-15/mill. annually  [1]. It is a 
life changing event that affects all bodily functions below the level of lesion with significant costs for 
the individual and society, and with consequences that predispose to cardiovascular risk factors 
such as dyslipidemia, vascular inflammation, insulin resistance, diabetes mellitus type 2, 
hypertension and overweight. Likewise abdominal adiposity is an independent risk factor for 
diseases associated with the metabolic syndrome [2]. Cardiovascular disease is one of the most 
frequent causes of death among people with SCI and occur among 46% of those who have lived 
for 30 years or more with a SCI, and 35% of people with a SCI who are 65 years or older [3]. The 
cardiovascular risk factor, including consequences of an inactive lifestyle and weight gain during 
and after the primary rehabilitation, defines the primary focus of the current project. 
The course of overweight  
The prevalence of overweight among people with SCI is high and is conservatively estimated to 
66% [4]. In a Swedish cohort of wheelchair dependent people with paraplegia, 27- 36% had a 
cardiovascular risk profile requiring treatment. When Body Mass Index (BMI) adjusted to SCI was 
entered into the risk model, 80% had a risk profile requiring treatment  [5]. Energy expenditure 
decreases significantly the first weeks after injury and remains low throughout the primary 
rehabilitation, with the possibility of decreasing even more the following years. Body fat and body 
weight also decreases in the acute phase, before increasing in the subacute phase towards the 
same level as before the time of injury [6]. A longitudinal study with participants ranging from 19- 
60 years of age and neurological level AIS A-D (54% where incomplete at follow up), found an 
average loss of lean body mass corresponding to 20,5 and 15, 1% in the lower extremities and 
trunk respectively during the first year after injury. The course among people with SCI during and 
after discharge from the primary rehabilitation in Denmark is not known. BMI increases gradually, 
and especially during the first years after discharge from the primary rehabilitation. A Dutch  
prospective cohort study found that BMI increased gradually with a prevalence of overweight of 28 
% during the primary rehabilitation and  54 % at follow up 5 years after discharge [7]. Similar 
inventories do not exist for people with SCI in Denmark. Obese people with SCI achieve a lower 
level of functioning during primary rehabilitation than people with normal weight [8], and more 
knowledge about prevention, treatment and managing overweight among people with SCI is 
warranted among health care professionals in the clinical setting. [9]. Overweight in people with 
SCI is associated with increased risk of depression, while physical activity may contribute to a 
decreased prevalence of depression and increased quality of life [10, 11]. The relationship 
between these variables in a Danish setting is not known.           
Impact of physical activity on health and fitness 
In the general population physical activity (PA) is associated with beneficial effects on diseases 
contributing to the metabolic syndrome including reduced fat mass, and may prevent weight gain 
as well as maintaining body weight after weight loss, and combined with diet the effect increases 
[12]. High aerobic capacity has an independent prophylactic effect on comorbidities due to obesity, 
and greater aerobic capacity is associated with greater cardiovascular health [13]. Until recently 
the recommendations for PA in the general population has, to a large extent, been the same for 
people with SCI. A systematic review from 2017 concerning the effect of exercise on fitness level 
and health among people with SCI, calls for guidelines about frequency, intensity and amount of 
exercise to enhance fitness and cardiometabolic health [14]. In October 2017, strictly evidence 
based exercise guidelines for cardiometabolic health was published for the first time, 

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recommending a minimum of 30 minutes of moderate to vigorous aerobic exercise three times 
weekly to reduce cardiovascular risk factors. However this recommendation does not include all 
AIS classifications, people at the age of 65+ or people with an acute SCI due to the lack of 
sufficient evidence . [15] [16] [17]. However an increased amount of PA in newly injured people 
with SCI is associated with more favorable lipid profiles and increased VO2peak during and after 
discharge from primary rehabilitation [18]. Changes in physical capacity during primary 
rehabilitation and the years after discharge has previously been described with an increase in 
VO2peak of 24% during the early phase of rehabilitation, and with a further increase one year after 
discharge. Koppenhagen et al found that VO2peak, despite different trajectories, increased over all 
in 88% of the participants during a period of 5 years [19, 20]. The course of VO2peak during and 
after discharge from primary rehabilitation in a Danish context is not known. After discharge from 
the primary rehabilitation the amount of PA in people with SCI is varying and 50- 63 % indicates to 
participate in little or no sports activity on a weekly basis. The majority of those who are physical 
active are active at mild to moderate intensity (54% and 68% respectively) [10, 15]. Intra- and extra 
personal factors are influencing participation in PA, including self-efficacy related to being 
physically active [21]. Therefore a new paradigm is focusing on avoiding inactivity [15]. The amount 
and intensity of PA in people with SCI in a Danish setting is not known. An association between 
self-reported PA and adherence to national nutritional guidelines is not necessarily present, and 
therefore focus on both elements is necessary during lifestyle changes [22].  
Prevention and treatment of cardiovascular risk factors  
In the literature an interdisciplinary approach to prevention and treatment  of cardiovascular risk 
factors including overweight and obesity  among people with SCI with a focus on diet, PA and 
behavioral interventions is recommended [15] [23]. A multimodal intervention is supported by a 
qualitative meta- synthesis, where diversity and a combination of several interventions is 
considered as most effective by people with a movement disability, including people with SCI, in 
order to promote a physical active lifestyle .Crucial components in the interventions, of which 
several also acts as outcome measures, are autonomy in relation to decision making related to PA, 
support and follow up from health care professionals as well as mentors with SCI, information 
about PA in relation to the diagnosis and finally behavioral interventions using goalsetting and 
feedback trough physical tests etc. [24]. The conclusion of the systematic review by Greaves et al 
is identical and states that interventions comprising of diet, PA, social support, increased frequency 
of follow ups, and the inclusion of goal setting and feedback are most effective to promote weight 
loss and PA. Besides the above mentioned, the systematic review recommend, on the basis of 
strong evidence, interventions in the clinical setting that contains both group sessions and 
individual sessions as well as interdisciplinary interventions that focus on maintaining PA and 
healthy diet [25]. 
Several studies have studied the effect of multimodal interventions comprising of diet ,PA and 
behavioral interventions, or some of these components, in people with SCI and the effect on 
different outcome measures such as bodyweight, BMI, lean body mass,  physical capacity and PA 
among others and with overall promising results [26] [21, 27] [28].  
Chen et al found that an intervention lasting 12 weeks, focusing on weight loss in 16 persons with 
SCI (AIS A-D) and BMI ≥25kg/m2, and consisted of weekly group sessions, where the participants 
and their partner were educated in nutrition, physical exercise and lifestyle changes, resulted in 
weight loss in 14 of the 16 participants with an average weight loss of 3,5 kg. 13 participated in  
follow up and had maintained their weight loss, three had gained weight and six participants had 
lost additional weight [27]. A RCT- study by Nooijen et al studied the effect of usual rehabilitation 
including hand biking 3 times weekly for 8 weeks in both groups, and 13 motivational counseling 

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sessions in the intervention group in order to facilitate PA and found significant effect of the 
motivational counseling sessions in relation to physical capacity and PA up to 12 months after 
discharge from primary rehabilitation. This study also explored the participants confidence in being 
physically active (self- efficacy) and found a strong relationship with physical capacity. A study by 
Liusuwan et al explored the effect of 16 weeks of group sessions, but also individual sessions, with 
instruction and education about nutrition, strength training and aerobic exercise, among children 
and adolescents with SCI and their parents. This study did not find any effect on body weight but 
found a significant effect in relation to lean body mass and physical capacity. Nash et al explored 
the effect of a national Diabetes Prevention Program customized to 7 men with SCI who were 
overweight and prediabetic. The program lasted 6 months and consisted of strength training 3 
times weekly, mediterranean diet with a daily calorie intake of 1200-2000 kcal and 16 individual 
sessions with a lifestyle coach. There was significant effect in terms of  reduced BMI and fasting 
blood glucose as well as increased physical capacity [28].   
While writing the project protocol, a user panel consisting of both newly injured as well as 
experienced people with SCI was established. All the participants were hospitalized at Clinic for 
Spinal Cord Injuries when they were interviewed about their perception of the present health 
promoting practice at the clinic. The user panel called for more information in the early phase of 
rehabilitation about cardiovascular risk, PA and diet as well as more support and guidance about 
being physical active and appropriate diet, which is the main aim the project.  
Hypothesis 
Targeted patient education in the form of  ”Strategic patient education” 1 in relation to an 
interdisciplinary, multimodal and patient activating intervention at Rigshospitalet,Clinic for Spinal 
Cord Injuries (CSCI), is expected to contribute to a decrease of cardiovascular risk factors and 
maintaineance of PA and healthy diet after discharge form the primary rehabilitation.  
 
Purpose  
The aim of this Ph.D project is to get an overview of the course of BMI among newly injured people 
with SCI in Denmark which serves as a historic control in conjunction with a systematic multimodal, 
intervention study, adapted to a Danish national setting with the aim of reducing cardiovascular risk  
factors and facilitating PA and healthy diet among all newly injured people with SCI during the 
primary rehabilitation and after discharge.  
 
Designs (Design description for each sub study). 
Sub study 1. Prospective representative longitudinal national survey of Body Mass Index.  
Sub study 2. An interdisciplinary multimodal longitudinal controlled intervention study 
Sub study 3. Test- retest reliability of VO2 peak  
Sub study 4. Test-retest reliability of a multi sensor accelerometer. 
 
 
Methods 
                                                           
1 Defined as face-to-face interaction between the patient and health care professionals in order to facilitate  
the patients skills working towards a goal, that  requires active patient participation related to decisions for 
one self and adherence to these. (See description under subproject 2) 

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Timeline for the project and used outcome measures 
 
 
Usual rehabilitation today 
Usual care during primary rehabilitation today before the intervention study (sub study 2), consists 
of interdisciplinary rehabilitation provided by doctors, nurses, physio-  and occupational therapists, 
psychologist and social workers with every single profession contributing with their expertise. 
According to the masterplan for patient care (“Patientforløbsbeskrivelsen” at Clinic for Spinal Cord 
Injuries (CSCI)) the patients neurological status (ISNCSCI), level of functioning (SCIM III), bowel 
and bladder function, cardiovascular and pulmonary function, medication, and psychological state 
is assessed at admission to CSCI. Non-SCI specific nutritional screening, assessment of body 
weight and screening for health related outcomes (diet, smoking, alcohol and exercise) is 
performed as well, but without a systematic approach and follow up.   
During rehabilitation, assessment of the above mentioned is repeated, and action is taken (if 
necessary) in relation to ADL functioning, musculoskeletal challenges including paralysis, 
spasticity, positioning in bed and wheelchair, as well as mobilization etc. A plan for the 
rehabilitation is made and adjusted continuously,  and includes several of the following elements 
such as  functional training (eg. transfers), strength training, cardiovascular exercise, functional 
electrical stimulation, wheelchair skills, hydrotherapy,  fine motor training of the upper 
extremities,eg. by creative activities and training of kitchen skills. Also continuously assessment 
and action is taken in relation to circulation, respiration, thermoregulation, bowel, bladder, skin, 
pain and spasticity, as well as assessment of the need for aids compensating the level of 
functioning, including communication aids and splinting. Counseling related to social and economic 
issues, sexual function and psychological issues is also provided if needed.  
During the rehabilitation, different educational workshops for the patients and their relatives about 
SCI and its consequences are held. Interdisciplinary meetings with the patient every 14 days are 
Prospective historic control VCR 
Prospective historic control CSCI 
Admission 
SOC, BMI,  
SCIM, ISNCSCI 
Discharge 
BMI, SCIM, ISNCSCI 
Admission 
SOC, BMI, SCIM,  
ISNCSCI, 
PHQ-2, QOL SCI, AH 
LTPAQ-SCI, 
Discharge 
BMI, SCIM, ISNCSCI,  
PHQ-2, QOL SCI, 
 LTPAQ -SCI, AH, ESES, 
AH, VO2 
Follow up  
BMI, SCIM, ISNCSCI, PHQ-2,  
QOL SCI, LTPAQ -SCI, AH, ESES 
Admission 
BMI, SCIM, ISNCSCI, SOC 
PHQ-2, QOL SCI,  
LTPAQ-SCI, VO2, 
DEXA, MP, AH, ESES, NORMON 
Discharge 
BMI, SCIM, ISNCSCI,  
PHQ-2, QOL SCI, 
 LTPAQ -SCI, VO2, 
DEXA, MP, AH,ESES, NORMON 
 
Follow up  
BMI, SCIM, ISNCSCI, 
 PHQ-2, QOL SCI,  
LTPAQ -SCI, AH, VO2, 
DEXA, MP, ESES, NORMON 
 
Intervention CSCI 
Timeline for the whole project 
Sept. 2017 
June 2018 
Aug. 2018 
June 2020 
SOC: Sociodemography BMI: Body Mass Index; SCIM: Spinal Cord Injury Indepence Measure; ISNCSCI: International Standards for Neurological 
Classification of Spinal Cord Injury; PHQ-2: Patient Health Questionnaire- 2; QOL SCI: International SCI Quality of Life Basic Data Set; VO2: Max. 
oxygen uptake; LTPAQ-SCI: Leisure Time Physical Activity Questionnaire for people With Spinal Cord Injury; AH Actiheart (accelerometer); 
DEXA; Dual- energy X-ray Absorptiometry ;MP: Metabolic  profile; ESES: Exercise Self Efficacy Scale 
”Wash out period” 
 

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held and goal setting and follow up is made. Evidence based tools for decision making which 
supports the patients’ decisions related to the first weekend at home and also decisions related to 
bladder management are used. Additionally, mentors with a SCI are available for the newly injured 
patients. During rehabilitation contact is established to the patient’s municipality to ensure the 
necessary aids, health care and overall support is provided to the patient after discharge from 
CSCI. Also contact to the national parasport organization is established if desired by the patient 
and membership of the patient organization is encouraged. During the rehabilitation the patients 
are in contact with several other medical specialties, and for instance investigations of the urinary 
tract are performed during the rehabilitation and repeated every 2 years afterwards. Outpatient 
follow up after discharge with a doctor and if necessary a nurse and physiotherapist is performed 
every 2 years. Focus on health promotion related to diet, smoking, alcohol and exercise in this 
setting is described in the masterplan for patient care at CSCI but not how this is carried out 
systematically.  
Although health promotion related to weight, diet, smoking, alcohol intake and physical activity is 
part of the usual rehabilitation in CSCI, a systematic approach, follow up and feedback is not 
provided.  Assessment of metabolic profile, body composition and physical capacity is not part of 
the usual care. In the masterplan for patient care at CSCI, health promoting initiatives are 
described as “communication and conversation with a health promoting purpose with the patient on 
a daily basis”.  How the communication is carried out in practice, and whether some health care 
professionals have a particular responsibility or expertise related to certain aspects of health 
promotion eg. based on tests or assessments of health, is unclear and not described in detail. A 
well described and systematic  approach related to health care promotion  may ensure that all 
patients at CSCI receive information and knowledge related to health promotion and the risk of 
cardiovascular disease. 
 Sub projects 
The project consists of a prospective national survey in collaboration with Spinal Cord Injury Centre 
of Western Denmark and an intervention at CSCI (see the timeline), which results in 4 sub projects 
 
Sub project 1. Prospective representative national survey of Body Mass Index.  
This study includes all patients with a new SCI hospitalized at CSCI or Spinal Cord Injury Center of 
Western Denmark during a period of 9 months whereby 100 patients are expected to participate. 
On the basis of usual rehabilitation today, data concerning BMI, level of functioning (SCIM III) and 
neurological status (ISNCSCI) are collected at admission and discharge. At CSCI BMI is collected 
every 6 weeks. Also the data for quality of life (QoL SCI), depression (PHQ-2), PA (LTPAQ-SCI) 
and self- assessed ability to be physically active (ESES) will be collected during this period and at 
follow up 6 months after discharge. A VO2peak test at discharge is performed and in some 
patients measurements of accelerometry (AH) will be performed. Patients with a new SCI who are 
admitted for rehabilitation several months after the time of injury are also included in the 
prospective survey. Therefore the data for BMI at the time of injury is collected for all patients at 
admission to primary rehabilitation from both the patient journal and also by asking the patient 
about weight and height at the time of injury. Data from this subproject serves as a historic control 
in the Ph.D project.  
 
Sub project 2. A systematic interdisciplinary multimodal intervention which, as a part of 
usual care, facilitates PA, healthy diet and maintenance after discharge through strategic 
patient education, with the aim of decreasing cardiovascular risk factors.  
 

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This pre- post study includes all patients with a new SCI who are admitted at CSCI during a period 
of 12- 18 months including follow up. Complete data sets from admission to follow up is expected 
for approximately 50-60 patients during this period. The multimodal,  interdisciplinary, patient 
activating and patient supportive intervention will be a part of usual care during the project period, 
and all newly injured patients will receive all the multimodal components, or parts of them, 
dependent on eg. the level of injury. Rehabilitation of the physical level of functioning and physical 
capacity will take place unchanged as usual.  
 
A central part of the intervention is to create a uniform and systematic approach when the patients  
receive information and instructions about cardiovascular risk factors, PA and a healthy diet 
through targeted strategic patient education, which includes targeted, individualized and 
systematic, face- to-face interaction between patients and health care professionals, while working 
towards, and improving a specific health related outcome through adherence to the working 
processes, medicine and lifestyle. The concept has been used previously for patient education and 
prophylaxis of catheter related sepsis [44]. Strategic patient education is carried out by all the 
health care professions in different settings with a focus on clarifying the importance of PA and a 
healthy diet. This will take place during the individual functional training and rehabilitation in 
general, and in conjunction with feedback about outcome measures and tests with subsequent 
instructions.  Strategic patient education will also be integrated as a concept in the education of the 
interdisciplinary health care professionals and mentors with a SCI, as they will be implementing the 
content of the education into a daily clinical setting. 
Pre-intervention education of health care professionals and mentors: Before onset of the 
intervention, all health care professionals and mentors with a SCI at CSCI will receive information 
and education about the content and elements of the intervention, cardiovascular risk factors in 
people with SCI and the effect of PA and healthy diet in order to establish a uniform knowledge at 
a basic level among all health care professionals and mentors at CSCI as called for in the literature 
[9]. The sessions are supplemented with evidence based recommendations that can be used by 
the health care professionals and mentors when they educate the patients. The review by Van Wyk 
et al emphasizes that patient education is an important part of the interdisciplinary rehabilitation of 
people with SCI and recommend an individualized approach and the use of different settings in 
which the patient can receive the education.  
Therefore the intervention will include an increased focus on cardiovascular risk factors and 
systematization of the existing setting and treatment interventions including education of patients- 
and their relatives in different in different types of forums [45, 46]. New interventions are introduced 
and several of the outcome measures at admission, discharge and follow up 6 months after 
discharge are a part of the intervention to facilitate PA and healthy diet through strategic patient 
education including body weight, body composition, metabolic profile, physical capacity, physical 
activity, self- assessed ability to be physically active and diet. Also included are instruction and 
information about PA and the intensity of this by using ratings of perceived exertion, identification 
of activity and participation problems related to PA and healthy diet using the Canadian 
Occupational Performance Measure, information about the recommended amount and composition 
of food on a plate at the lunch and evening servings but also in conjunction with kitchen training 
and grocery shopping with the occupational therapists.  A motivational conversation, tools for 
decision making, and use of mentors with SCI to facilitate PA and healthy diet are also introduced.   
Patient adherence to the elements of the intervention is described descriptively by registration of 
their participation in the different elements in which they are expected to participate. The 
adherence of the interdisciplinary health care professionals in relation to the intervention is 

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described and secured by a process inspired by a previously used prospective effect and process 
evaluation [47].  
 
  
Table of interventions, methods, personnel resources, setting and frequency 
Interventions in the 
existing setting 
Method 
Personnel 
requirements 
Work flow and 
setting  
Frequency 
Patient education by 
the doctors  
Education 
Doctors 
Existing setting 
and work flows 
are used and 
systematized  
 
During the 
primary 
rehabili- 
tation 
 
Education cafe 
Education  
Interdisciplinary 
Education of the 
relatives 
Education  
Interdisciplinary  
Cardiovascular 
exercise and 
wheelchair skills 
sessions 
Education/ practical 
Physiotherapists 
Occopational therapy 
Education/practice/goal 
setting 
Occopational therapists 
The Hospital kitchen 
Supervision and guidance 
related to diet 
composition 
Kitchen staff 
Meetings for goal 
setting  
Meeting between the 
patient and the 
interdisciplinary health 
care professionals 
Interdisciplinary 
Existing setting 
and work flows 
are used and 
systematized 
every 14 days 
Interventions beyond 
the existing setting  
Method 
Personnel 
requirements  
Work flow and 
setting  
Frequency 
Education of the 
health care personnel  
Education 
Ph.D student +  in- and 
external teachers  
All health care 
personnel  
  
Same lecture  
x 2 or more 
before the 
intervention 
Patient Decision Aids  
Patient Decision Aids 
related to physical activity 
and healthy diet s + use of 
mentors with SCI 
Interdisciplinary 
Developed   
from the 
existing 
template  
Early stage 
after 
admission  
Motivational 
counseling 
One session during 
primary rehabilitation 
Selected health  
care providers with 
expertise 
Provided time 
and setting 
Early stage 
after 
admission  
 
Test and outcome 
measures 
Method 
Personnel 
requirements  
Work flow and 
setting  
Admission* 
Discharge* 
Follow up* 
After 
terminated 
Ph.D project* 

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Oxygen uptake 
Objective PA 
Bodyweight 
Body composition 
Metabolic profile 
Level of functioning 
Neurological  status 
Depression 
Quality of Life 
Self - reported 
physical activity 
 
Self- assessed ability 
to be physically active 
 
Measure of patient 
participation /shared 
decision 
 
Measure for a varied 
and healthy diet in an 
appropriate amount 
 
VO2peak test 
Accelerometer 
Weighing 
Dexa scan 
Blood sample 
SCIM 
ISNCSCI 
Questionnaire 
Questionnaire 
Questionnaire 
 
 
Questionnaire 
 
 
Questionnaire 
 
 
 
Questionnaire 
 
Ph.D student** 
Ph.D student** 
Nurses 
Secretaries/doctors 
Nurse/doctor/secretary 
Interdisciplinary 
Physiotherapists 
Doctors  (admission)# 
Nurses (discharge)# 
Ph.D student 
 
 
Ph.D student 
 
 
Ph.D student 
 
 
 
Ph.D student 
 
Exercise test 
- 
Existing 
Glostrup  Hosp. 
Existing 
Existing 
Existing 
Existing 
Existing 
- 
 
 
- 
 
 
- 
 
 
 
- 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
*1-2 weeks after admission and before discharge Follow up approx. 6 months after discharge. 
** Is handled by physiotherapists with knowledge and skills after the project.   
# Is handled by the Ph.D student at discharge and admission for depression and quality of life 
respectively. 
Subproject 3. Test- retest reliability of a VO2 peak test  
This study includes all patients participating in subproject 1 who are able of performing the test. A 
seated cross-trainer is used (NuStep T5XR) with an incorporated test protocol in the equipment 
software. Equipment and protocol is reliable in people with traumatic brain injury and has been 
validated in healthy persons [32, 33]. In people with an incomplete SCI the equipment is safe, and 
involves a large amount of muscle mass ensuring completion of the test [34]. The equipment may 
also be used by patients with a complete SCI of the lower extremities, but in case the equipment is 
difficult to use for people with a complete tetraplegia, an armcrancking ergometer will be used (SCI 
FIT Pro1). The reliability of the cross-trainer has not previously been evaluated in people with SCI. 
The test- retest study takes place at discharge, separated by 48 hours or within maximum 5 days 
at the same time of the day. The participants refrain from caffeine, alcohol and intensive physical 
exercise on the day of testing as well as tobacco smoking to hours before the test. Bladder 
emptying is taken care off before the test.  
 
Subproject 4. Test-retest reliability of a multi censor accelerometer. 

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This study includes a subsample of 20 patients participating in subproject 1. The equipment used 
for monitoring amount and intensity of PA consists of censors registering acceleration and heart 
rate and is placed on the thorax of the participant with two surface electrodes. The equipment has 
previously been used in wheelchair dependent people with SCI, although the reliability of the 
equipment has not previously been assessed [35]. The precision of the equipment is higher when 
calibrated individually to the participant using an exercise test [68]. In this project individual 
calibration will be made during the exercise test described in subproject 3, and continuous 
measurements of amount and intensity of PA will be made during a period of 24 hours. The test- 
retest is performed at discharge, separated by 48 hours or within maximum 5 days at the same 
time of the day.  
 
Outcome measures 
All outcome measures will be collected at admission, discharge and follow-up 6 months after 
discharge. At CSCI data for BMI is also collected every 6`th week during the hospitalization period.  
Primary outcome 
Oxygen uptake: Is measured as VO2peak during a maximal exercise test and is gold standard for 
measuring aerobic capacity. For people with a SCI several test protocols have been used [36]. The 
test in this project is performed by using the integrated test protocol in the software of NuStep XR5 
or SCI FIT Pro 1. Gradual increments in workload is added every minute depending on the level of 
lesion. The participant maintains a fixed cadence until predefined criteria for VO2peak is reached 
after 8-12 minutes. If VO2peak is not reached during this period the workload increases each 
minute until VO2peak [36, 67]  
Secondary outcomes 
Objective physical activity: Is measured in a sub-sample in the historic control cohort and the 
participants in the intervention study with a multisensor device (Actiheart®) recording accelerations 
and heart rate. It is previously used for wheelchair users with a SCI and individual calibration is 
important to get the most accurate data [29].  
Bodyweight:  Is measured as Body Mass Index (BMI) which is the most widely used outcome 
measure for measuring bodyweight in people with SCI. BMI is not sensitive enough to distinguish 
between fat mass and lean body mass nor overweight in people with SCI. Lowering the cut-off for 
overweight to 25kg/m2  the sensitivity increases although this adjustment is not used consequently 
in the literature [30]. BMI is already collected as part of the existing routines every week and data 
for BMI every 6`th week until discharge will be included in the project. Some newly injured are 
admitted to primary rehabilitation several months after the time of injury, and the course of 
bodyweight may already have changed significantly since the time of injury. Therefore BMI at the 
time of injury is collected from the patient journal from the initial hospitalization during the acute 
stage and by asking the patient at admission to primary rehabilitation about the height and weight 
at the time of injury.   
Body composition:  Is determined by  Dual energy x-ray absorbtiometry (Dexa) which is gold 
standard for assessing obesity and body composition although cut-off values for people with SCI 
has not been established [30]. 
Metabolic profile: Consists of CRP as a marker for inflammation, BP, Lipid profile: Total 
cholesterol, Triglycerides, HDL cholesterol, LDL cholesterol which all are included in the 
International SCI Endocrine and Metabolic Function Basic Data Set, as well as Hemoglobin A1c as 

11 
 
a marker for carbohydrate metabolism, and is included in the International SCI Endocrine and 
Metabolic Extended Data Set [31, 32].  
Level of functioning: Is determined by the Spinal Cord Injury Independence Measure III (SCIM 
III) which is a valid and reliable outcome measure designed to assess level of functioning in people 
with SCI in a clinical setting and in research  [33] [34, 35]. The SCIM is composed of 19 items that 
assess 3 domains.1 Self-care (6 items, scores range from 0-20). 2 Respiration and sphincter 
management (4 items, scores range from 0-40). 3 Mobility (9 items, scores range from 0-40). The 
total SCIM scores range from 0 to 100. SCIM III is already collected as part of the existing routines 
at CSCI.  
Neurological status:  Is determined by the International Standards for Neurological Classification 
of Spinal Cord Injury (ISNCSCI) and is the most widely used classification in people with SCI [36, 
37].  The classification tool involves a sensory and motor examination to determine the neurological 
level of the injury and whether the injury is complete or incomplete. The ISNCSCI defines 
neurological level as the most caudal level at which sensory and motor function are intact. The 
completeness of the injury is graded according to the ASIA Impairment Scale (AIS). AIS is used to 
determine the degree of motor and sensory function below the level of the SCI. A complete or 
incomplete injury is defined as absence or presence of sensory and motor function in the most 
caudal sacral segment. A = complete; B = sensory incomplete without motor function > 3 levels 
below the motor level of injury on both sides of the body; C = motor incomplete, with preserved 
motor function below the level of injury and where > 50% of the key muscles below the injury level 
have a degree < 3 by MMT; D = motor incomplete with preserved motor function below the level of 
injury and where > 50% of key muscles below the injury level have a degree > 3 by MMT; E = 
normal sensory and motor function in all segments. ISNCSCI Is already collected as part of the 
existing routines at CSCI.  
Depression: Is measured by the Patient Health Questionnaire- 2 (PHQ-2) which is a generic 
outcome measure for measuring depression. In people with SCI a cut-off score of 3 is associated 
with a sensitivity of 83,3% and specificity of  95,7% [38].  PHQ-2 is already collected at admission 
as part of the existing routines at CSCI  
Quality of Life: Is measured by the International SCI Quality of Life Basic Data Set (QoL SCI) 
which consists of three questions regarding satisfaction with life in general as well as physical and 
mental health. It is a  valid outcome measure with good internal consistency [39] [40]. QoL SCI is 
already collected at discharge as part of the existing routines at CSCI. 
Self - reported physical activity: Is measured by the Leisure Time Physical Activity 
Questionnaire for people with Spinal Cord Injury (LTPAQ-SCI) which is a self- administered 
questionnaire concerning leisure time PA, including amount and intensity the past 7 days. LTPAQ- 
SCI uses a scale for perceived exertion which is validated against VO2-peak and the Borg-scale. 
Reliability and validity of the self- reported activity level is satisfactory in the moderate and high 
intensity area [13]. For people hospitalized during primary rehabilitation, defining leisure time may 
be difficult. Therefore an instruction defining leisure time in this context was formulated describing 
leisure time PA as being PA that is not part of the patients weekly schedule, is not planned 
together with the health care professionals as part of the rehabilitation and is not self- administered 
exercise which is planned or scheduled as part of the rehabilitation. Therefore leisure time PA is 
any kind of spontaneous PA that is not planned or schedule together with a physiotherapist or 
other health care professionals. This kind of necessary PA is described in the additional question 
developed for the study. The question will be designed as the original questions and the same 
intensity scale is used. 

12 
 
Self- assessed ability to be physically active: Is measured by the Exercise Self Efficacy Scale 
for people with Spinal Cord Injury (ESES) which is an outcome measure developed for assessing  
self- efficacy related to PA in people with SCI, and consists of 10 questions which are answered on 
a 0-4 scale. ESES is reliable with a high internal consistency (Cronbach`s alpha 0,94).  Also 
content validity in the form of face and construct validity are satisfactory  [41].  
Measure of patient participation /shared decision making 
Measure for a varied and healthy diet in an appropriate amount:  Is measured by the Nordic 
monitoring of diet, physical activity and overweight (NORMON). The questionnaire Is used to 
measure the course in dietary habits and explores how often 16 food indicators are consumed. The 
food indicators are chosen in a way that reflects the diets nutritional quality. An association 
between the frequency of food indicator intake and the overall nutritional value of the diet is 
present. Several of the chosen food indicators are recommended in the national nutritional 
recommendations, and through the questions, it is possible to achieve knowledge about how many 
of the participants who eat fish twice a week, how many who eat six pieces of fruit or vegetables a 
day etc. The questionnaire was validated in 2009 against existing questionnaires about diet [42]. 
The outcome measure is developed in a Nordic collaboration and has been used for common 
monitoring of the diet habits, physical activity level and overweight of the Nordic population in 2011 
and 2014 [43]. In the Ph.D project the questions related to alcohol intake and smoking are also 
used.   
Clinical implications of the project 
The project will contribute to a uniform and increased focus as well as knowledge among the 
interdisciplinary health care professionals at CSCI and VCR, about preventing cardiovascular risk 
factors and health promotion. The project will also contribute to organizational changes including 
implementation of new work flows and knowledge about how these changes all together 
contributes to the initiation and maintaineance of PA and healthy diet. Even though new treatment 
initiatives are  introduced, a lot of the existing workflows and settings are used and the intervention 
or major parts of this is expected to continue as a part of the standard treatment  at CSCI after the 
project is terminated, and hopefully contribute to prevent cardiovascular disease in future newly 
injured people with SCI.  
Name of the investigator and trial site  
Nicolaj Jersild Holm, PT, MSc. Rigshospitalet, Neuroscience centre Clinic for Spinal Cord Injuries, 
Havnevej 25, DK 3100 Hornbæk. E-mail: nicolaj.jersild.holm@regionh.dk phone.:+ 45 38 63 19 45. 
Trial registration 
The project is reported to the Danish Data Protection Agency 
 
Data storage 
Informed consent is obtained by the Ph.D student in conjunction with the procedure for recruitment 
of participants (see later). 
Data from the patient journals in Epic and the different outcome measures used, is stored in a web 
based database (Redcap) which is created by the regional Centre for IT, Medico and Telephony 
(CIMT), with limited access and ID- code, to which pseudo anonymized data is transferred directly, 
Feltkode ændret
Feltkode ændret

13 
 
or via an encrypted USB-stick. An identification list is stored in a locked cabinet at CSCI, local 
3403. 
Data is stored until December 31, 2027 after which paper material is shredded and data files are 
deleted. 
Statistics  
The intervention study and follow up is performed as a pragmatic study and includes, with a few 
exceptions, all newly injured patients with SCI admitted to primary highly specialized rehabilitation 
at CSCI. Patients will be included during a time period of 18 corresponding to approximately 40 – 
60 patients. Due to the rareness of the morbidity a power calculation is not performed for the 
primary outcome prior to the intervention, but it is assumed that the total participant number in the 
intervention and in the historic control cohort, will be comparable to the existing scientific literature.  
Numeric continuous data collected at admission, discharge and follow up is reported descriptively 
as mean and standard deviation together with 95% confidence intervals, or as median, upper and 
lower quartile as well as interquartile range. Changes over time is reported on the basis of paired t-
test. In subproject 3 and 4 the reliability of the outcome measures is analyzed by paired t-test, 
Pearsons product moment correlation and coefficient of variation or Intraclass correlation 
coefficient between the test- retest sessions. 
 
Participants, inclusion- and exclusion criteria 
Inclusion criteria: All newly injured patients within the previous 12 months, with a SCI and admitted 
at CSCI are included, regardless of age, neurological level of lesion and completeness of the 
injury. In subproject 1 all newly injured people with SCI admitted at VCR are also included. Patients 
under the age of 18 will participate if informed consent is retrieved from their parents. 
Exclusion criteria: Insufficient skills in Danish language and reduced mental function that prevents 
reading and answering the questionnaires. For the VO2peak test: Motor complete SCI (AIS A and 
B) at C4 level or above and assisted ventilatory function. Other exclusion criteria are the presence 
of decubitus, severe spasticity or musculoskeletal problems considered at risk of aggravation 
during testing or preventing completion of the test.  
 
Recruitment of participants:  
 
All newly injured patients who are admitted for rehabilitation at CSCI during the project period are 
included in the intervention (subproject 2) as it becomes a part of usual care during the project 
period. The Ph.D student is informed about new and future admissions at CSCI by local patient 
lists every week, and LTPAQ-SCI, ESES, QoL_ SCI  and NORMON is handed out  to the patient 
and collected again by the Ph.D student. Date and time for the VO2peak test is handed to the 
patients physiotherapist, who will make sure to enter it into the patients weekly schedule. The 
same procedure is repeated at discharge except that QoL_SCI is collected as a part of existing 
procedures and PHQ-2 is collected by the Ph.D student. In subproject 1, data for VO2peak at 
CSCI will only be collected at discharge. All newly injured patients who are admitted for 
rehabilitation at VCR in the same period are recruited for subproject 1 and data for BMI, SCIM III 
and ISNCSCI is collected as a part of existing procedures in usual care.  

14 
 
The coordination related to booking of the Dexa- scan and transportation for this is managed by 
the secretaries. Ordination of the Dexa- scan as well as blood samples related to metabolic profile 
is handled by the doctors.    
 
Ethical considerations  
During the intervention period all newly injured patients who are admitted for rehabilitation are 
offered the treatment and tests included in the intervention to the extent they are able to participate 
depending on eg. the level of lesion and completeness of the injury, as this is a part of usual care 
and will continue as a part of usual care after termination of the project. The regional ethical 
committee will be contacted to clarify the need to report sub project 2 while the intervention in the 
project is closely related with the content of the present rehabilitation, why the risk of pain and 
discomfort related to the elements in the intervention is considered modest. Patients who are re-
hospitalized for control visit will not be a part of the project and will receive usual rehabilitation.  
During the VO2peak test, there will be special attention on symptoms of autonomic dysreflexia  
(AD) in people with SCI above T5-6. Several symptoms may be present and include a 20mm Hg 
increase in systolic blood pressure above baseline, headache, flushing and cold sweating above 
the level of injury. In this case the exercise test is disrupted and relevant actions are initiated, such 
as loosening of tight clothes, an upright positioning depending on the severity of AD. If the exercise 
test results in orthostatic hypotension (OH) the test is disrupted and the patient is placed in a 
horizontal position with elevation of the lower extremities above heart level.  
Any unintended events related to the elements of the intervention is reported according to existing 
guidelines. 
It is assumed that any risks is by far surpassed by the therapeutic gains such as an expected risk 
reduction of cardiovascular disease and consequently mortality. 
Funding and organization  
This work was supported by a mutual cooperation about the research program ” Centre for 
Integrated Rehabilitation of Cancer Patients (CIRE) - Neuro/Psychology”,  between the University 
Hospitals Centre for Health Care Research (UCSF), University hospital Copenhagen, 
Rigshospitalet, Blegdamsvej 9, section 9701 (Ryesgade 27, DK- 2100 Copenhagen); the 
Metropolitan University College (Metropol),Institute for Nursing, the Health and Technological 
Faculty, Tagensvej 86, DK- 2200 Copenhagen and the NeuroScience Centre, section 2091; 
Rigshospitalet, Blegdamsvej 9, DK- 2100 Copenhagen; Neurologic department, Nordsjællands 
Hospital and Psychiatric centre, Glostrup Hospital.  
The initiative behind the neuro/psyk programme consists of reseachers and leaders from UCSF 
and Metropol, as well as the steering committee of UCSF consisting of representatives from the  
hospital directors in the Capital region (Vicedirector for University hospital Copenhagen, 
Rigshospitalet Helen Berndt Andersen, hospitalsdirector for Nordsjællands hospital Bente Ourø, 
vicedirector for the pshychiatri in the capital region Anne Hertz, and associate dekan Metropol 
Randi Brinckmann Wiencke). 
The project gruop in relation to the Ph.D projektet consist of  senior researcher Tom Møller (UCSF, 
head supervisor), professor Fin Biering-Sørensen (Neuroscience centre Rigshospitalet, Clinic for 
Spinal Cord Injuries, co-supervisor), Docent Lone Schou (Metropol, co- supervisor), professor Lis 
Adamsen (UCSF), senior researcher Julie Midtgaard (UCSF), head nurse Hanne Folden Lindholdt 
(Clinic for Spinal Cord Injuries), leading therapist Janni Sleimann (Clinic for Spinal Cord Injuries 

15 
 
Clinic for Spinal Cord Injuries), clinical nurse specialist Line Dalsgaard (Clinic for Spinal Cord 
Injuries) and center manager nurse (Vibeke Freilev (Neuroscience centre, Rigshospitalet. 
 
Interests of conflict  
The Ph.D student has no interests of conflict related to the project in general or any of the 
subprojects  
Risk assessment and changes to the protocol 
The completion of the Ph.D project may come in danger if the intervention elements and workflows  
are not implemented by one or several of the interdisciplinary professions, or if the necessary data 
are not collected by the interdisciplinary professions. If this appears to be the case during collection 
of data from the patients journal in Epic or it is expressed by the staff at staff meetings, the 
responsible department managers will be informed in order to ensure the implementation of the 
elements. 
The Ph.D project may also come in danger if the patients are engaged in other research projects 
parallel to the Ph.D project, which is considered to be most likely, but since the Ph.D project 
comprises the patients standard treatment, the risk that the patients participation in other research 
projects will affect  the Ph.D project is considered modest. Also the Ph. D project may  come in 
danger if the patients does not consent to the use of  their data in the project.  
A significant challenge to the project, and a factor able to impact on the projects completion is the 
logistic planning related to the patients having the necessary tests made at the right times at 
admission, discharge and follow up, for which they need to be called in for.  
Some of the data used in project and many of the settings and work flows used in the intervention  
is a part of the existing settings and procedures, which is ensuring the completion of the project.  
At Clinic for Spinal Cord Injuries the clinic management by head nurse Hanne Folden Lindholdt, 
leading therapist Janni Sleimann and head of the clinic Claus Andersen are responsible for 
ensuring the setting necessary for completing the project and its elements. At an overall level 
center manager nurse Vibeke Freilev, Neuroscience centre, Rigshopitalet is responsible for 
ensuring the necessary setting for the completion of the project.  
Changes to the protocol will be described in an additional protocol. 
Publication of results:  
Attempts will be made to publish the projects results in relevant scientific journal such as BMJ 
Open, Archives of Physical Rehabilitation Medicine, Journal of Spinal Cord Medicine and Spinal 
Cord. Listed below are the preliminary titles of the articles. 
The Ph.D student will be primary author on all articles primary supervisor Tom Møller will be last 
author on articles related to subproject 2, 3 and 4, while co- supervisors Fin Biering-Sørensen and  
Lone Schou are last authors on articles related to subproject  1 and the protocol article 
respectively. Clinical nurse specialist Line Dalsgaard is co- author on the protocol article and the 
article related to subproject 1 
Protocol article: Health and Cardiovascular Risk Reduction in People with Spinal Cord Injury - 
Physical Activity, Healthy Diet and Adherence after Discharge from Primary Rehabilitation.  

16 
 
1. Longitudinal National Survey of Body Mass Index and Measures of Functional Recovery, 
Depression, Quality of life, Physical Activity and Exercise Self Efficacy during Inpatient Spinal Cord 
Injury Rehabilitation and Follow Up. 
2.  Effects of a Systematic and Interdisciplinary, Multimodal and Patient Engaging Intervention on  , 
Metabolic  Markers, Body Composition, Physical Activity and Diet, Quality of Life and Exercise Self 
Efficacy during Inpatient Rehabilitation with Follow up, Facilitating Adaptation to Physical Activity 
and Healthy Diet  in People with Spinal Cord Injury.   
3. Test-retest reliability of VO2 peak using a recumbent stepper in persons with spinal cord injury. 
4. Test-retest reliability of a multi sensor device monitoring amount and intensity of physical activity 
in spinal cord injured persons during inpatient rehabilitation and at follow up.  
I relation to subproject 2 there may be a possibility to prepare an article in collaboration with  
Sunnaas Sykehus in Oslo, Norway, where a planned Ph.D project has the same overall focus. 
Results for SCIM III, ISNCSCI, VO2peak, BMI, Metabolic profile, DEXA and QoL SCI in the two 
projects may be published.   
 
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