Clinical trial NCT04862481: Physical Function of Older Citizens During Municipality-based Rehabilitation
Official title: Older Citizens During Municipality-based Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Rehabilitation
Frailty
Sarcopenia
Fractures, Bone
Musculoskeletal Pain
Musculoskeletal Diseases
Musculoskeletal Injury
Muscle Weakness
Weakness, Muscle
Keywords: SMFA
SF36
ICF
OLDER
REHABILITATION
Lead sponsor: University College Absalon
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Sundhed og Træning, Slagelse Municipality
name: Danish Council for Independent Research
First posted: 2021-04-28
Enrollment: 115
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants from Slagelse municipality's community-based health centre will be recruited in the period January 2021- June 2021 or until 115 men and woman have been included.

To detect a correlation coefficient of minimum r=+/-0.3 with a significance level of 0.05 and power of 0.8 between the primary outcome SMFA and the generic health-related quality of life questionnaire SF36 a minimum of 85 participants are needed based on the Fisher's z test.

Some studies have shown a response rate for the SMFA to be approximately 65% in cross-sectional studies, we, therefore add another 35% extra participants to the calculated sample size, resulting in a target of 115 participants to be initially included in the study.

Brief summary: When choosing outcomes to assess rehabilitation's effect or progress, it is essential to consider the constructs being measured and their value to the patient and the psychometric properties. Choosing an outcome that reflects all aspects of International Classification levels of Functioning, Disability and Health (ICF) is challenging, especially in heterogeneous groups. However, it is important to know the psychometric properties as this gives important knowledge on how to interpret results and, consequently, how this can inform the patient's care. The Short Musculoskeletal Function Assessment (SMFA) questionnaire can reflect differences in patients' functional status with a broad range of disorders, like for elderly citizens undergoing municipality-based rehabilitation. Nevertheless, since there is no golden standard to measure rehabilitation outcomes, construct validity needs to be established to investigate how scores of SMFA can be related to measures on all levels of ICF.

Therefore, this study has three main objectives:

1. To investigate how scores of the SMFA questionnaire are related to measures on different ICF levels
2. To describe the characteristics of older citizens starting municipality-based rehabilitation on all ICF levels
3. To investigate predictor variables of upper- and lower extremity strength

Detailed description: The present study is a sub-study to the Randomized Controlled Trial (NCT04091308).

The present study aims to include 115 participants who will undergo measures specified in the "Outcome" section. The principal investigator of the study will conduct the testing.

Eligibility criteria: Inclusion Criteria:

All citizens that are referred to the health/rehabilitation center aged ≥ 65 years 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,
* Active cancer,
* Upper or lower limb amputations,
* Hypertension \>180/110,
* Referred to rehabilitation primarily due to gynecological or neurological conditions (apoplexies) or surgeries where movement restrictions prohibit participating in most of the tests,
* Discouragement from a general practitioner.

Primary outcomes:
measure: Measure of physical functioning with Short Musculoskeletal Function Assessment (SMFA)
timeFrame: Baseline
Secondary outcomes:
measure: Measure in health-related quality of life with Short Form 36 (SF-36)
timeFrame: Baseline
Other outcomes:
measure: Measure of mobility with The New Mobility Score
timeFrame: Baseline
measure: Measure of the PRISMA-7 score
timeFrame: Baseline
measure: Measure of the Tilburg Frailty Scale score
timeFrame: Baseline
measure: Measure of pain (region of pain, intensity of pain, duration of pain), physical activity level and demographic information
timeFrame: Baseline
measure: Measure of weight
timeFrame: Baseline
measure: Measure of height
timeFrame: Baseline
measure: Measure of blood pressure
timeFrame: Baseline
measure: Measure of resting heart rate
timeFrame: Baseline
measure: Measure of lean body mass
timeFrame: Baseline
measure: Measure of fat percentage
timeFrame: Baseline
measure: Measure of total body water
timeFrame: Baseline
measure: Measure of visceral fat
timeFrame: Baseline
measure: Measure of basic metabolic rate (BMR)
timeFrame: Baseline
measure: Measure of Waist-To-Hip ratio
timeFrame: Baseline
measure: Measure of maximal isometric voluntary contraction of leg extension
timeFrame: Baseline
measure: Measure of handgrip strength
timeFrame: Baseline
measure: Measure of shoulder strength
timeFrame: Baseline
measure: Measure of elbow strength
timeFrame: Baseline
measure: Measure of leg press strength
timeFrame: Baseline
measure: Measure of knee extension strength
timeFrame: Baseline
measure: Measure of calf extension strength
timeFrame: Baseline
measure: Measure of gait distance with the two minutes walk test (2MWT)
timeFrame: Baseline
measure: Measure of heart rate before and after the two minutes walk test (2MWT)
timeFrame: Baseline
measure: Measure of Rating Perceived Exertion using The Borg Scale before and after the two minutes walk test (2MWT)
timeFrame: Baseline
measure: Measure of function using the Timed Up and Go test (TUG)
timeFrame: Baseline
measure: Measure of balance using the Tandem test
timeFrame: Baseline
measure: Measure of balance and reaction time for upper and lower extremity
timeFrame: Baseline
measure: Estimation of protein and energy intake
timeFrame: Baseline
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: