Physical Function of Older Citizens During Municipality-based Rehabilitation

Aging Clinical Trial

Official title:

Older Citizens During Municipality-based Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04862481
• Other study ID #: SJ758
• Secondary ID: 8045-00052B
• Status: Completed
• Start date: January 25, 2021
• Est. completion date: September 12, 2021

Study information

• Verified date: March 2022
• Source: University College Absalon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: September 12, 2021
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Fractures, Bone
• Frailty
• Muscle Weakness
• Musculoskeletal Diseases
• Musculoskeletal Injury
• Musculoskeletal Pain
• Rehabilitation
• Sarcopenia
• Weakness, Muscle

Locations

Country	Name	City	State
Denmark	Sundhed og Træning	Slagelse	Zealand

Sponsors (4)

Lead Sponsor	Collaborator
University College Absalon	Danish Council for Independent Research, Sundhed og Træning, Slagelse Municipality, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	Measure of weight	Weight will be measured in kilograms	Baseline
Other	Measure of height	Height will be measured in meters	Baseline
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Measure of handgrip strength	The handgrip strength (in kilograms) will be measured using a hydraulic handgrip dynamometer (SAEHAN).	Baseline
Other	Measure of shoulder strength	The shoulder abduction strength (in kilograms) will be measured using a handheld dynamometer.	Baseline
Other	Measure of elbow strength	The elbow flexion and extension strength (in kilograms) will be measured using a handheld dynamometer.	Baseline
Other	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
Other	Measure of knee extension strength	Five repetitions maximum (RM) strength tests will be performed in knee extension (in kilograms) to calculate one RM.	Baseline
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Estimation of protein and energy intake	Protein and energy intake will be estimated based on 24-hour dietary recall interviews.	Baseline
Primary	Measure of physical functioning with Short Musculoskeletal Function Assessment (SMFA)	Self reported	Baseline
Secondary	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