Clinical trial NCT04091308: Individualized Physical Exercise Training and Enhanced Protein Intake in Older Citizens During Municipality-based Rehabilitation
Official title: Individualized Physical Exercise Training and Enhanced Protein Intake in Older Citizens During Municipality-based Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Keywords: Exercise
Protein supplementation
Physical exercise training
Lead sponsor: University College Absalon
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Sundhed og Træning, Slagelse Municipality
name: Arla Foods
name: Danish Council for Independent Research
name: Association of Danish Physiotherapists
First posted: 2019-09-16
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will investigate if: 1) individualized physical exercise training in combination with extra protein intake can increase measures on all three ICF-levels? 2) extra protein intake alone increases outcomes of usual care treatment?

Detailed description: Successful rehabilitation of the growing number of elderly citizens can lead to preservation of functional independence and improvement in the quality of life.

The aim of the study is to investigate the effect of an individually tailored physical exercise training program combined with increased protein intake in order to improve measures on all three ICF levels (International Classification of Functioning, Disability, and Health). By conducting the study in a real-life clinical setting, research is translated into practice involving health professionals and the target group in the development of new knowledge on how to enhance the outcome of rehabilitation, thereby increasing the overall capacity of the elderly citizen, and decreasing the expenditure of health-services.

Eligibility criteria: Inclusion Criteria:

All citizens that are referred to the health/rehabilitation center age 65 years and older from Slagelse municipality will be invited to a screening interview with a physiotherapist after which the participant will be asked to join the study if not subject to one of the following exclusion criteria's:

Exclusion Criteria:

* inability to speak or read Danish,
* renal diseases,
* active cancer,
* upper or lower limp amputations,
* milk/lactose allergy or intolerance,
* hypertension \>180/110,
* pacemaker/other implanted electrical stimulants (due to Bio-Impedance Analysis),
* progressive somatic or psychiatric diseases which can affect the course of training,
* referred to rehabilitation primarily due to gynecological and neurological conditions (apoplexies) or surgeries where movement restrictions are recommended,
* daily medication that may have an impact on muscle protein synthesis,
* alcohol intake greater than 14 units per week,
* discouragement from a general practitioner.

Primary outcomes:
measure: Short Musculoskeletal Function Assessment (SMFA) - Dysfunction Index
timeFrame: Change from: baseline to 3 months (primary endpoint) and 12 months
Secondary outcomes:
measure: Mean change from baseline in mobility with The New Mobility Score
timeFrame: Change from: baseline to 3 months and 12 months
measure: Mean change from baseline in the PRISMA-7 score
timeFrame: Change from: baseline to 3 months and 12 months
measure: Mean change from baseline in the Tilburg Frailty Scale score
timeFrame: Change from: baseline to 3 months and 12 months
measure: Mean change from baseline in health-related quality of life on SF-36
timeFrame: Change from: baseline to 3 months and 12 months
measure: Measure of pain, physical activity level and educational level
timeFrame: Change from: baseline to 3 months and 12 months
measure: Mean change from baseline in weight
timeFrame: Change from: baseline to 3 months and 12 months
measure: Measure of height at baseline
timeFrame: Baseline
measure: Mean change from baseline in blood pressure
timeFrame: Change from: baseline to 3 months and 12 months
measure: Mean change from baseline in resting heart rate
timeFrame: Change from: baseline to 3 months and 12 months
measure: Mean change from baseline in body composition measured with a bioimpedance device
timeFrame: Change from: baseline to 3 months and 12 months
measure: Mean change from baseline in the basic metabolic rate (BMR)
timeFrame: Change from: baseline to 3 months and 12 months
measure: Mean change from baseline of Waist-To-Hip ratio
timeFrame: Change from: baseline to 3 months and 12 months
measure: Mean change from baseline in maximal isometric voluntary contraction of leg extension
timeFrame: Change from: baseline to 3 months and 12 months
measure: Mean change from baseline in handgrip strength
timeFrame: Change from: baseline to 3 months and 12 months
measure: Mean change from baseline in leg press strength
timeFrame: Change from: baseline to 3 months and 12 months
measure: Mean change from baseline in knee extension strength
timeFrame: Change from: baseline to 3 months and 12 months
measure: Mean change from baseline in calf extension strength
timeFrame: Change from: baseline to 3 months and 12 months
measure: Mean change from baseline in function measured with the 2 minutes walk test (2MWT)
timeFrame: Change from: baseline to 3 months and 12 months
measure: Mean change from baseline in heart rate during 2 minutes walk test (2MWT)
timeFrame: Change from: baseline to 3 months and 12 months
measure: Mean change from baseline in heart rate before and after the 2 minutes walk test (2MWT)
timeFrame: Change from: baseline to 3 months and 12 months
measure: Mean change from baseline in The Borg Rating of Perceived Exertion before and after the 2 minutes walk test (2MWT)
timeFrame: Change from: baseline to 3 months and 12 months
measure: Mean change from baseline in function measured with the Timed Up and Go test (TUG)
timeFrame: Change from: baseline to 3 months and 12 months
measure: Mean change from baseline in balance measured with the Tandem test
timeFrame: Change from: baseline to 3 months and 12 months
measure: Balance and reaction time for upper and lower extremity
timeFrame: Change from: baseline to 3 months and 12 months
measure: Protein and energy intake
timeFrame: Change from: baseline, week 3, week 6, week 9, 3 months and 12 months
Other outcomes:
Locations:
city: Slagelse
country: Denmark
facility: Sundhed og Træning
state: Zealand
Study officials:
affiliation: University College Absalon & University of Southern Denmark
name: Sanel Teljigovic, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Teljigovic S, Sogaard K, Sandal LF, Dalager T, Nielsen NO, Sjogaard G, Holm L. Individualised physical exercise training and enhanced protein intake in older citizens during municipality-based rehabilitation: protocol for a randomised controlled trial. BMJ Open. 2020 Nov 26;10(11):e041605. doi: 10.1136/bmjopen-2020-041605.