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HIFT for People With Mobility-Related Disabilities (Research GO)

Primary Purpose

Mobility Limitation, Physical Disability

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIFT for people with MRD
Sponsored by
University of Kansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mobility Limitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years of age and older
  • have a permanent disability that affects mobility (1 year +);
  • Never been a part of a functional fitness program before
  • no significant health impairment that would contraindicate exercise (physician clearance required)
  • serve as their own guardian

Exclusion Criteria:

  • younger than 18 years of age
  • have a disability that was acquired within 1 year of starting the study or has a non-permanent mobility limitation (e.g., broken arm);
  • has previously been involved in functional fitness
  • unable to obtain physician clearance
  • Are not their own guardian

Sites / Locations

  • University of KansasRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIFT for People with MRD

Arm Description

12-week, thrice weekly HIFT intervention for adults with MRD at a local facility that currently hosts HIFT for people with disability and, thus, is conducive to the training needs of individuals with MRD. We will provide financial support for 12-week membership costs, transportation, and participant compensation for completing pre- and post-intervention assessments. Baseline and post-intervention testing will include assessments of weight, body composition, flexibility, and strength, in addition to quality of life, sense of community, self-determination, sleep, and life satisfaction. Each participant will also have energy expenditure assessed during two, randomly selected HIFT sessions during the 12-wk intervention.

Outcomes

Primary Outcome Measures

Body Mass Index
Weight will be measured in duplicate using a portable calibrated, digital scale to the nearest 0.1 kg. Height will be measured in meters, and body mass index (BMI) will be calculated with the following formula: kg/m2
Skinfold
3-site skinfold test as outlined by Jackson & Polloc (1978; 1980) on 3 site measures (men: chest, abdomen, thigh; women: triceps, suprailium, thigh). The same investigator will measure all 3 sites using a Harpenden Skinfold Caliper in triplicate, and the true skinfold thickness was taken as an average of teh three measures.
Strength
Grip Strength with dynameter. Participants will be seated with elbow flexed at 90 degrees, forearm in a neutral position and write between 0 and 30 degrees of flexion. participants will use their dominant hand and the 5 second squeeze will occur in duplicate, with 15 second rest in between and the score averaged to the nearest 0.1 kg.
Flexibility
Back Scratch Test (Jones & Rikli, 2002) - 1 arm above the head, bent elbow, reach down across the back as far as possible. Simultaneously, the opposite arm bent at elbow and forearm is extended up along the back as far as possible to that the fingers of both hands meet or overlap. The distance of overlap or the distance between the tips of the middle fingers is measured in centimeters.
Strength 5-repeition max
Participants will complete 5-repetition max strength testing at week 2 of the intervention, and again at week 12. This will include a 5-RM assessment of the deadlift, press (standing or seated) and squat. Outcome variables will be reported to the nearest kg with regard to weight successfully moved for 5 repetitions.
Work Capacity
Participants will complete 2 work capacity tests during week 3 (A1) and 5 (A2), and again at weeks 10 (A1) and 12 (A2). A1 will be assessed by the outcome measure of time to complete the benchmark exercise session - in minutes and seconds; and A2 will be assessed by number of rounds and repetitions completed during the exercise session in a given amount of time.

Secondary Outcome Measures

Perceived Functional Performance
The Canadian Occupational Therapy Measure (COPM) is a valid and reliable standardized assessment used to identify occupational performance problems experienced by a client. Performance areas report by the client as challenging or unable to do will be documented in a list. Then the client will rate the perceived importance of each problem area on the list. Only the most important performance areas (top five maximum) will be included in the COPM assessment. The client will then rate their current performance ability and satisfaction of their ability for each of these performance areas. The client's ratings of importance, performance ability, and satisfaction will be used to calculate the client's baseline average occupational performance and satisfaction of their ability. Baseline average performance and satisfaction scores are then used to determine if a client's occupational performance improvements occur over time (Law et al., 1990)
Perceived Quality of Life
World Health Organization Quality of Life (WHOQOL-BREF) (Skevington et al., 2004; Bonomi & Patrick, 1997) an internationally recognized and established short measure assessing quality of life. For the purposes of this study, we will include three of the four domains (physical health, psychological health, social relationships) to evaluate perceived health-related quality of life as a component of psychological well-being.
Life Satisfaction
the Satisfaction with Life Questionnaire (Kobau eta l., 2010; Post et al., 2012) will be used as an additional assessment of well-being.
Self-determination
Behavioral Regulation in Exercise Questionnaire (BREQ-2; Markland & Tobin, 2004) will assess changes to perceived behavioral regulation (autonomous vs. external regulation) with in the functional fitness environment. 19 items with 5 subscales (external, introjected, identified, and intrinsic)
Psychological Need Satisfaction
The Psychological Need Satisfaction in Exercise Questionnaire (PNSE; Wilson et al., 2006) will be used to assess need satisfaction within the functional fitness environment. Include three subscale autonomy, competence, and relatedness
Sense of Community
The Sense of Community Scale (SOC; Warner et al., 2013) will be used to assess perceptions of community among the administration, social spaces, other members and competition
Shoulder Pain - wheelchair users only
The Wheelchair User's Shoulder Pain Index (WUSPI) will be used to assess self-report changes in shoulder pain during daily functional activities with a 10-point visual analog scale (Curtis et al., 1995a, b)
Exercise Self-efficacy
28-item Self-Related Abilities for Health Practices Scale (SRAHP) to assess self-efficacy scores regarding exercise, nutrition, health practices and psychological well-being (Becker et al., 1993).
Sleep
Sleep Disturbance Short Form (PROMIS Health Organization, 8b) will be used to assess self-report sleep quality in the past 7 days.
Barriers to Health
The 16-item Barriers to Health Adapted for People with Disabilities (BHAPD) will assess participant self-report of perceived motivational and external barrier to exercise (Becker et al., 1991)

Full Information

First Posted
July 29, 2022
Last Updated
August 22, 2022
Sponsor
University of Kansas
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1. Study Identification

Unique Protocol Identification Number
NCT05516030
Brief Title
HIFT for People With Mobility-Related Disabilities
Acronym
Research GO
Official Title
Exploring High-intensity Functional Training for People With Mobility-related Disability: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
April 4, 2023 (Anticipated)
Study Completion Date
April 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Investigators will examine the feasibility and health outcomes following a high-intensity functional training intervention for people with mobility-related disabilities. In addition to participant recruitment, attritions rates, and satisfaction, investigators will assess changes to both physical health outcomes (e.g., strength, body composition) and psychosocial outcomes (e.g., quality of life). The findings will provide evidence for the efficacy of HIFT to improve various health outcomes for a population that experiences health disparities in access to, and engagement in, community-based exercise.
Detailed Description
The proposed study will examine the feasibility and effectiveness of a high intensity functional training (HIFT) pilot study for adults with mobility-related disabilities (MRD). Aim 1 will explore the feasibility of a 12-week, thrice weekly HIFT intervention for adults with MRD. Investigators will evaluate participant acceptability and satisfaction, document recruitment challenges, attrition rates, and the adaptive elements of the program for replication and improvement to future clinical trials. Aim 2 will assess the effects of HIFT participation on participant health outcomes, including (i) fitness factors such as work capacity, strength, and energy expenditure; (ii) functional performance; (iii) body composition and weight; and (iv) variables contributing to psychological well-being such as motivation, quality of life, and life satisfaction. A relatively novel mode of exercise, HIFT stands out for its inclusive approach and adaptable programming, which has the potential to improve health outcomes for a novel target population. The proposed research activities will provide initial data on the feasibility and expected magnitude of change in multiple dimensions of health for people with MRD and contribute to the limited evidence of community-based programs that are adaptable and inclusive. The findings will also allow for the mobilization of this knowledge into disability and healthcare communities to increase the recommendations for exercise for this population and inform future design of clinical trials.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation, Physical Disability

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIFT for People with MRD
Arm Type
Experimental
Arm Description
12-week, thrice weekly HIFT intervention for adults with MRD at a local facility that currently hosts HIFT for people with disability and, thus, is conducive to the training needs of individuals with MRD. We will provide financial support for 12-week membership costs, transportation, and participant compensation for completing pre- and post-intervention assessments. Baseline and post-intervention testing will include assessments of weight, body composition, flexibility, and strength, in addition to quality of life, sense of community, self-determination, sleep, and life satisfaction. Each participant will also have energy expenditure assessed during two, randomly selected HIFT sessions during the 12-wk intervention.
Intervention Type
Other
Intervention Name(s)
HIFT for people with MRD
Intervention Description
12-wk, 3x/week HIFT participation for individuals with MRD
Primary Outcome Measure Information:
Title
Body Mass Index
Description
Weight will be measured in duplicate using a portable calibrated, digital scale to the nearest 0.1 kg. Height will be measured in meters, and body mass index (BMI) will be calculated with the following formula: kg/m2
Time Frame
Change from Baseline BMI at 13 weeks (post-intervention)
Title
Skinfold
Description
3-site skinfold test as outlined by Jackson & Polloc (1978; 1980) on 3 site measures (men: chest, abdomen, thigh; women: triceps, suprailium, thigh). The same investigator will measure all 3 sites using a Harpenden Skinfold Caliper in triplicate, and the true skinfold thickness was taken as an average of teh three measures.
Time Frame
Change from Baseline 3-site skinfolds at 13 weeks (post-intervention)
Title
Strength
Description
Grip Strength with dynameter. Participants will be seated with elbow flexed at 90 degrees, forearm in a neutral position and write between 0 and 30 degrees of flexion. participants will use their dominant hand and the 5 second squeeze will occur in duplicate, with 15 second rest in between and the score averaged to the nearest 0.1 kg.
Time Frame
Change from baseline strenghth at 13 weeks (post-intervention)
Title
Flexibility
Description
Back Scratch Test (Jones & Rikli, 2002) - 1 arm above the head, bent elbow, reach down across the back as far as possible. Simultaneously, the opposite arm bent at elbow and forearm is extended up along the back as far as possible to that the fingers of both hands meet or overlap. The distance of overlap or the distance between the tips of the middle fingers is measured in centimeters.
Time Frame
Change from Baseline flexibility at 13 weeks (post-intervention)
Title
Strength 5-repeition max
Description
Participants will complete 5-repetition max strength testing at week 2 of the intervention, and again at week 12. This will include a 5-RM assessment of the deadlift, press (standing or seated) and squat. Outcome variables will be reported to the nearest kg with regard to weight successfully moved for 5 repetitions.
Time Frame
Change in Week 2 strength at week 12 of the intervention
Title
Work Capacity
Description
Participants will complete 2 work capacity tests during week 3 (A1) and 5 (A2), and again at weeks 10 (A1) and 12 (A2). A1 will be assessed by the outcome measure of time to complete the benchmark exercise session - in minutes and seconds; and A2 will be assessed by number of rounds and repetitions completed during the exercise session in a given amount of time.
Time Frame
Change in baseline work capacity at weeks 10 and 12 of the intervention
Secondary Outcome Measure Information:
Title
Perceived Functional Performance
Description
The Canadian Occupational Therapy Measure (COPM) is a valid and reliable standardized assessment used to identify occupational performance problems experienced by a client. Performance areas report by the client as challenging or unable to do will be documented in a list. Then the client will rate the perceived importance of each problem area on the list. Only the most important performance areas (top five maximum) will be included in the COPM assessment. The client will then rate their current performance ability and satisfaction of their ability for each of these performance areas. The client's ratings of importance, performance ability, and satisfaction will be used to calculate the client's baseline average occupational performance and satisfaction of their ability. Baseline average performance and satisfaction scores are then used to determine if a client's occupational performance improvements occur over time (Law et al., 1990)
Time Frame
Change from Baseline perceived functional performance at 13 weeks (post-intervention)
Title
Perceived Quality of Life
Description
World Health Organization Quality of Life (WHOQOL-BREF) (Skevington et al., 2004; Bonomi & Patrick, 1997) an internationally recognized and established short measure assessing quality of life. For the purposes of this study, we will include three of the four domains (physical health, psychological health, social relationships) to evaluate perceived health-related quality of life as a component of psychological well-being.
Time Frame
Change from Baseline QOL at 13 weeks (post-intervention)
Title
Life Satisfaction
Description
the Satisfaction with Life Questionnaire (Kobau eta l., 2010; Post et al., 2012) will be used as an additional assessment of well-being.
Time Frame
Change from Baseline life satisfaction at 13 weeks (post-intervention)
Title
Self-determination
Description
Behavioral Regulation in Exercise Questionnaire (BREQ-2; Markland & Tobin, 2004) will assess changes to perceived behavioral regulation (autonomous vs. external regulation) with in the functional fitness environment. 19 items with 5 subscales (external, introjected, identified, and intrinsic)
Time Frame
Change from Baseline self-determination at 13 weeks (post-intervention)
Title
Psychological Need Satisfaction
Description
The Psychological Need Satisfaction in Exercise Questionnaire (PNSE; Wilson et al., 2006) will be used to assess need satisfaction within the functional fitness environment. Include three subscale autonomy, competence, and relatedness
Time Frame
Change from Baseline need satisfaction at 13 weeks (post-intervention)
Title
Sense of Community
Description
The Sense of Community Scale (SOC; Warner et al., 2013) will be used to assess perceptions of community among the administration, social spaces, other members and competition
Time Frame
Change from Baseline sense of community at 13 weeks (post-intervention)
Title
Shoulder Pain - wheelchair users only
Description
The Wheelchair User's Shoulder Pain Index (WUSPI) will be used to assess self-report changes in shoulder pain during daily functional activities with a 10-point visual analog scale (Curtis et al., 1995a, b)
Time Frame
Change from Baseline shoulder pain at 13 weeks (post-intervention)
Title
Exercise Self-efficacy
Description
28-item Self-Related Abilities for Health Practices Scale (SRAHP) to assess self-efficacy scores regarding exercise, nutrition, health practices and psychological well-being (Becker et al., 1993).
Time Frame
Change from Baseline self-efficacy at 13 weeks (post-intervention)
Title
Sleep
Description
Sleep Disturbance Short Form (PROMIS Health Organization, 8b) will be used to assess self-report sleep quality in the past 7 days.
Time Frame
Change from Baseline sleep at 13 weeks (post-intervention)
Title
Barriers to Health
Description
The 16-item Barriers to Health Adapted for People with Disabilities (BHAPD) will assess participant self-report of perceived motivational and external barrier to exercise (Becker et al., 1991)
Time Frame
Change from Baseline perceived barriers at 13 weeks (post-intervention)
Other Pre-specified Outcome Measures:
Title
Energy Expenditure
Description
energy expenditure will be assessed at two, randomly selected sessions for each participant. This will be done using a previously validated portable, open-circuit indirect calorimeter (Cosmed, Italy) which measures breath-by-breath ventilation, expired oxygen, and carbon dioxide. The flow turbine will be calibrated using a 3.0-L syringe. The lightweight (~1.5 kg) portable system will be attached by a harness around the waist and shoulders of the participant before each assessment. During exercise sessions, participants will breathe into a facemask that directs air into the unit housing the O2 and CO2 analyzers. Data will be retrieved for analysis via a serial port interface and software provided with the calorimeter and aggregated over 20-second epochs for the calculation of 1-min averages.
Time Frame
Week 3 and Week 9 of the intervention
Title
Attendance
Description
Participant attendance for the functional fitness sessions will be recorded
Time Frame
Observed each week of the 12-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years of age and older have a permanent disability that affects mobility (1 year +); Never been a part of a functional fitness program before no significant health impairment that would contraindicate exercise (physician clearance required) serve as their own guardian Exclusion Criteria: younger than 18 years of age have a disability that was acquired within 1 year of starting the study or has a non-permanent mobility limitation (e.g., broken arm); has previously been involved in functional fitness unable to obtain physician clearance Are not their own guardian
Facility Information:
Facility Name
University of Kansas
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lyndsie Koon, PhD
Phone
785-864-1611
Email
lyndsiek@ku.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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HIFT for People With Mobility-Related Disabilities

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