Physical Function of Older Citizens During Municipality-based Rehabilitation

Sponsor

University College Absalon (Other)

Overall Status

Completed

CT.gov ID

NCT04862481

Collaborator

University of Southern Denmark (Other), Sundhed og Træning, Slagelse Municipality (Other), Danish Council for Independent Research (Other)

115

Enrollment

Location

7.6

Actual Duration (Months)

15.2

Patients Per Site Per Month

Study Details

Study Description

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:

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

Condition or Disease	Intervention/Treatment	Phase
Aging Rehabilitation Frailty Sarcopenia Fractures, Bone Musculoskeletal Pain Musculoskeletal Diseases Musculoskeletal Injury Muscle Weakness Weakness, Muscle

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.

Study Design

Study Type:

Observational

Actual Enrollment :

115 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Older Citizens During Municipality-based Rehabilitation

Actual Study Start Date :

Jan 25, 2021

Actual Primary Completion Date :

Sep 10, 2021

Actual Study Completion Date :

Sep 12, 2021

Outcome Measures

Primary Outcome Measures

Measure of physical functioning with Short Musculoskeletal Function Assessment (SMFA) [Baseline]
Self reported

Secondary Outcome Measures

Measure in health-related quality of life with Short Form 36 (SF-36) [Baseline]
The SF-36 is a generic questionnaire that measures health-related quality of life in the past four weeks. The questionnaire consists of 36 questions which are divided into eight sub-scales and summarized in two sum scores. Higher scores indicate better health status.

Other Outcome Measures

Measure of mobility with The New Mobility Score [Baseline]
The New Mobility Score assesses the patient's walking function inside, outside, and during shopping. Including whether a walking aid is used. The NMS provides a composed score of the participants' mobility. Each question is scored between 0-3 points, depending on the degree of help. The total possible score is between 0 and 9 points.
Measure of the PRISMA-7 score [Baseline]
The PRISMA-7 questionnaire is composed of seven items and is used to indicate frailty among participants - each question scores either 0 or 1 points. The total possible score is between 0 and 7 points.
Measure of the Tilburg Frailty Scale score [Baseline]
The Tilburg Frailty Scale is a questionnaire with a bio-psycho-social approach, which measures frailty. It is composed of 15 multidimensional questions, regarding the physical, psychological, and social aspects of human functioning. Scoring range is between 0-15 points.
Measure of pain (region of pain, intensity of pain, duration of pain), physical activity level and demographic information [Baseline]
A survey with self-formulated questions regarding name, sex, personal ID (CPR number), educational level, the region of pain the last three months (marked on a body chart), pain intensity and pain duration at the most painful body region the last three months, and physical activity level will also be collected.
Measure of weight [Baseline]
Weight will be measured in kilograms
Measure of height [Baseline]
Height will be measured in meters
Measure of blood pressure [Baseline]
Systolic and diastolic blood pressure (mmHg) will be measured using the Omron HBP 1100 blood pressure and resting heart rate monitor.
Measure of resting heart rate [Baseline]
Resting heart rate (in beats per minute) will be measured using the Omron HBP 1100 blood pressure and resting heart rate monitor.
Measure of lean body mass [Baseline]
The electrical bioimpedance device used in the present study to measure changes in body composition is the "Tanita 9MC-780U Multi Frequency Segmental Body Composition Analyzer". Lean body mass will be measured in kilograms.
Measure of fat percentage [Baseline]
The electrical bioimpedance device used in the present study to measure changes in body composition is the "Tanita 9MC-780U Multi Frequency Segmental Body Composition Analyzer". Lean body mass will be measured in kilograms. Fat percentage will be measured as a percentage of the total body mass.
Measure of total body water [Baseline]
The electrical bioimpedance device used in the present study to measure changes in body composition is the "Tanita 9MC-780U Multi Frequency Segmental Body Composition Analyzer". Lean body mass will be measured in kilograms. Total body water will be measured as percentage of the total body mass.
Measure of visceral fat [Baseline]
The electrical bioimpedance device used in the present study to measure changes in body composition is the "Tanita 9MC-780U Multi Frequency Segmental Body Composition Analyzer". Lean body mass will be measured in kilograms. Visceral fat will be measured on a scale ranging between 1-59. Scores above 12 indicate an unhealthy level of visceral fat.
Measure of basic metabolic rate (BMR) [Baseline]
BMR will be estimated by a bioelectrical impedance analysis device "Tanita 9MC-780U Multi Frequency Segmental Body Composition Analyze" in kilojoules.
Measure of Waist-To-Hip ratio [Baseline]
The circumference of the waist (in centimeters) will be divided with the circumference of the hip (in centimeters) to report the Waist-to-hip ratio.
Measure of maximal isometric voluntary contraction of leg extension [Baseline]
A maximal isometric voluntary contraction (in newtons) for knee extension will be performed using a strain gauge.
Measure of handgrip strength [Baseline]
The handgrip strength (in kilograms) will be measured using a hydraulic handgrip dynamometer (SAEHAN).
Measure of shoulder strength [Baseline]
The shoulder abduction strength (in kilograms) will be measured using a handheld dynamometer.
Measure of elbow strength [Baseline]
The elbow flexion and extension strength (in kilograms) will be measured using a handheld dynamometer.
Measure of leg press strength [Baseline]
Five repetitions maximum (RM) strength tests will be performed in the leg press (in kilograms) to calculate one RM.
Measure of knee extension strength [Baseline]
Five repetitions maximum (RM) strength tests will be performed in knee extension (in kilograms) to calculate one RM.
Measure of calf extension strength [Baseline]
Five repetitions maximum (RM) strength tests will be performed in the calf extension (in kilograms) to calculate one RM
Measure of gait distance with the two minutes walk test (2MWT) [Baseline]
The 2MWT will measure the distance (in meters) a person can walk in two minutes. Gaits speed will be calculated by dividing the covered distance with the time (two minutes).
Measure of heart rate before and after the two minutes walk test (2MWT) [Baseline]
Heart rate (in BPM) will be measured (using the Apple Watch serie 5) before and right after the 2MWT.
Measure of Rating Perceived Exertion using The Borg Scale before and after the two minutes walk test (2MWT) [Baseline]
The Borg Rating of Perceived Exertion 6-20 scale will be used to estimate the activity intensity before and right after the 2MWT. Higher numbers indicate higher exertion.
Measure of function using the Timed Up and Go test (TUG) [Baseline]
Time is noted (in seconds) on how long it takes to get up from a chair, walk three meters, turn around and go back to the chair and sit down again.
Measure of balance using the Tandem test [Baseline]
A measure of static balance will be performed using a Tandem test. The participants will be tested in three positions for ten seconds each (feet together, semi tandem and full tandem). Time is noted (in seconds) for how long the participant can stand in each position
Measure of balance and reaction time for upper and lower extremity [Baseline]
Measures for balance and reaction time will be collected using the "Fysiometer," and the protocols within the "Fysiometer" software will be followed.
Estimation of protein and energy intake [Baseline]
Protein and energy intake will be estimated based on 24-hour dietary recall interviews.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.