Physical Function of Older Citizens During Municipality-based Rehabilitation

Older Citizens During Municipality-based Rehabilitation

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

Study Overview

• Status: Completed
• Conditions: Fractures, Bone; Musculoskeletal Diseases; Musculoskeletal Pain; Muscle Weakness; Frailty; Sarcopenia; Aging; Rehabilitation; Musculoskeletal Injury; 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 Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• Denmark
  • Zealand
    • Slagelse, Zealand, Denmark, 4200
      • Sundhed og Træning

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of physical functioning with Short Musculoskeletal Function Assessment (SMFA)	Self reported	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure in health-related quality of life with Short Form 36 (SF-36)	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.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of mobility with The New Mobility Score	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.	Baseline
Measure of the PRISMA-7 score	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.	Baseline
Measure of the Tilburg Frailty Scale score	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.	Baseline
Measure of pain (region of pain, intensity of pain, duration of pain), physical activity level and demographic information	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.	Baseline
Measure of weight	Weight will be measured in kilograms	Baseline
Measure of height	Height will be measured in meters	Baseline
Measure of blood pressure	Systolic and diastolic blood pressure (mmHg) will be measured using the Omron HBP 1100 blood pressure and resting heart rate monitor.	Baseline
Measure of resting heart rate	Resting heart rate (in beats per minute) will be measured using the Omron HBP 1100 blood pressure and resting heart rate monitor.	Baseline
Measure of lean body mass	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.	Baseline
Measure of fat percentage	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.	Baseline
Measure of total body water	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.	Baseline
Measure of visceral fat	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.	Baseline
Measure of basic metabolic rate (BMR)	BMR will be estimated by a bioelectrical impedance analysis device "Tanita 9MC-780U Multi Frequency Segmental Body Composition Analyze" in kilojoules.	Baseline
Measure of Waist-To-Hip ratio	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.	Baseline
Measure of maximal isometric voluntary contraction of leg extension	A maximal isometric voluntary contraction (in newtons) for knee extension will be performed using a strain gauge.	Baseline
Measure of handgrip strength	The handgrip strength (in kilograms) will be measured using a hydraulic handgrip dynamometer (SAEHAN).	Baseline
Measure of shoulder strength	The shoulder abduction strength (in kilograms) will be measured using a handheld dynamometer.	Baseline
Measure of elbow strength	The elbow flexion and extension strength (in kilograms) will be measured using a handheld dynamometer.	Baseline
Measure of leg press strength	Five repetitions maximum (RM) strength tests will be performed in the leg press (in kilograms) to calculate one RM.	Baseline
Measure of knee extension strength	Five repetitions maximum (RM) strength tests will be performed in knee extension (in kilograms) to calculate one RM.	Baseline
Measure of calf extension strength	Five repetitions maximum (RM) strength tests will be performed in the calf extension (in kilograms) to calculate one RM	Baseline
Measure of gait distance with the two minutes walk test (2MWT)	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).	Baseline
Measure of heart rate before and after the two minutes walk test (2MWT)	Heart rate (in BPM) will be measured (using the Apple Watch serie 5) before and right after the 2MWT.	Baseline
Measure of Rating Perceived Exertion using The Borg Scale before and after the two minutes walk test (2MWT)	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.	Baseline
Measure of function using the Timed Up and Go test (TUG)	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.	Baseline
Measure of balance using the Tandem test	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	Baseline
Measure of balance and reaction time for upper and lower extremity	Measures for balance and reaction time will be collected using the "Fysiometer," and the protocols within the "Fysiometer" software will be followed.	Baseline
Estimation of protein and energy intake	Protein and energy intake will be estimated based on 24-hour dietary recall interviews.	Baseline

Collaborators and Investigators

• Sponsor: University College Absalon
• Collaborators: University of Southern Denmark; Danish Council for Independent Research; Sundhed og Træning, Slagelse Municipality
• Investigators: Principal Investigator: Sanel Teljigovic, PhD student, University College Absalon & University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Actual): September 10, 2021
• Study Completion (Actual): September 12, 2021

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: ICF; SF36; REHABILITATION; SMFA; OLDER
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Muscular Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Muscle Weakness; Frailty; Sarcopenia; Fractures, Bone; Musculoskeletal Pain; Musculoskeletal Diseases; Asthenia
• Other Study ID Numbers: SJ758; 8045-00052B (Danish Council for Independent Research)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No