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Completed

NCT Number: NCT04862481

Physical Function of 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

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Key information

Conditions

Aging Atrophy Fractures, Bone Frailty Muscle Weakness Muscular Atrophy Muscular Diseases Musculoskeletal Diseases Musculoskeletal Injury Musculoskeletal Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rehabilitation Sarcopenia Signs and Symptoms Weakness, Muscle Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sundhed og Træning

Slagelse, Region Sjælland, 4200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Measure of physical functioning with Short Musculoskeletal Function Assessment (SMFA)

    Time frame: Baseline

    Self reported

Secondary outcomes

  1. Measure in health-related quality of life with Short Form 36 (SF-36)

    Time frame: 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 outcomes

  1. Measure of mobility with The New Mobility Score

    Time frame: 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.

  2. Measure of the PRISMA-7 score

    Time frame: 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.

  3. Measure of the Tilburg Frailty Scale score

    Time frame: 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.

  4. Measure of pain (region of pain, intensity of pain, duration of pain), physical activity level and demographic information

    Time frame: 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.

  5. Measure of weight

    Time frame: Baseline

    Weight will be measured in kilograms

  6. Measure of height

    Time frame: Baseline

    Height will be measured in meters

  7. Measure of blood pressure

    Time frame: Baseline

    Systolic and diastolic blood pressure (mmHg) will be measured using the Omron HBP 1100 blood pressure and resting heart rate monitor.

  8. Measure of resting heart rate

    Time frame: Baseline

    Resting heart rate (in beats per minute) will be measured using the Omron HBP 1100 blood pressure and resting heart rate monitor.

  9. Measure of lean body mass

    Time frame: 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.

  10. Measure of fat percentage

    Time frame: 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.

  11. Measure of total body water

    Time frame: 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.

  12. Measure of visceral fat

    Time frame: 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.

  13. Measure of basic metabolic rate (BMR)

    Time frame: Baseline

    BMR will be estimated by a bioelectrical impedance analysis device "Tanita 9MC-780U Multi Frequency Segmental Body Composition Analyze" in kilojoules.

  14. Measure of Waist-To-Hip ratio

    Time frame: 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.

  15. Measure of maximal isometric voluntary contraction of leg extension

    Time frame: Baseline

    A maximal isometric voluntary contraction (in newtons) for knee extension will be performed using a strain gauge.

  16. Measure of handgrip strength

    Time frame: Baseline

    The handgrip strength (in kilograms) will be measured using a hydraulic handgrip dynamometer (SAEHAN).

  17. Measure of shoulder strength

    Time frame: Baseline

    The shoulder abduction strength (in kilograms) will be measured using a handheld dynamometer.

  18. Measure of elbow strength

    Time frame: Baseline

    The elbow flexion and extension strength (in kilograms) will be measured using a handheld dynamometer.

  19. Measure of leg press strength

    Time frame: Baseline

    Five repetitions maximum (RM) strength tests will be performed in the leg press (in kilograms) to calculate one RM.

  20. Measure of knee extension strength

    Time frame: Baseline

    Five repetitions maximum (RM) strength tests will be performed in knee extension (in kilograms) to calculate one RM.

  21. Measure of calf extension strength

    Time frame: Baseline

    Five repetitions maximum (RM) strength tests will be performed in the calf extension (in kilograms) to calculate one RM

  22. Measure of gait distance with the two minutes walk test (2MWT)

    Time frame: 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).

  23. Measure of heart rate before and after the two minutes walk test (2MWT)

    Time frame: Baseline

    Heart rate (in BPM) will be measured (using the Apple Watch serie 5) before and right after the 2MWT.

  24. Measure of Rating Perceived Exertion using The Borg Scale before and after the two minutes walk test (2MWT)

    Time frame: 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.

  25. Measure of function using the Timed Up and Go test (TUG)

    Time frame: 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.

  26. Measure of balance using the Tandem test

    Time frame: 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

  27. Measure of balance and reaction time for upper and lower extremity

    Time frame: Baseline

    Measures for balance and reaction time will be collected using the "Fysiometer," and the protocols within the "Fysiometer" software will be followed.

  28. Estimation of protein and energy intake

    Time frame: Baseline

    Protein and energy intake will be estimated based on 24-hour dietary recall interviews.

Sponsors and collaborators

Lead sponsor

University College Absalon

Other

Collaborators

  • Danish Council for Independent Research
  • Sundhed og Træning, Slagelse Municipality
  • University of Southern Denmark

Registry information

Official study title

Older Citizens During Municipality-based Rehabilitation

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 28, 2021
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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