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Physical Function of Older Citizens During Municipality-based Rehabilitation

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ClinicalTrials.gov Identifier: NCT04862481
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : April 28, 2021
Sponsor:
Collaborators:
University of Southern Denmark
Sundhed og Træning, Slagelse Municipality
Danish Council for Independent Research
Information provided by (Responsible Party):
Sanel Teljigovic, University College Absalon

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

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 115 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Older Citizens During Municipality-based Rehabilitation
Actual Study Start Date : January 25, 2021
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation




Primary Outcome Measures :
  1. Measure of physical functioning with Short Musculoskeletal Function Assessment (SMFA) [ Time Frame: Baseline ]
    Self reported


Secondary Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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 >180/90,
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04862481


Contacts
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Contact: Sanel Teljigovic, PhD student 004572482689 sate@pha.dk

Locations
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Denmark
Sundhed og Træning Recruiting
Slagelse, Zealand, Denmark, 4200
Contact: Louise Overlade    +4558575320    louov@slagelse.dk   
Sponsors and Collaborators
University College Absalon
University of Southern Denmark
Sundhed og Træning, Slagelse Municipality
Danish Council for Independent Research
Investigators
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Principal Investigator: Sanel Teljigovic, PhD student University College Absalon & University of Southern Denmark
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Responsible Party: Sanel Teljigovic, Principal Investigator, University College Absalon
ClinicalTrials.gov Identifier: NCT04862481    
Other Study ID Numbers: SJ758
8045-00052B ( Other Identifier: Danish Council for Independent Research )
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sanel Teljigovic, University College Absalon:
SMFA
SF36
ICF
OLDER
REHABILITATION
Additional relevant MeSH terms:
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Musculoskeletal Pain
Muscle Weakness
Musculoskeletal Diseases
Sarcopenia
Frailty
Fractures, Bone
Pathologic Processes
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Muscular Diseases
Pain
Wounds and Injuries