Mobility LimitationResearch GONCT05516030
HIFT for People With Mobility-Related Disabilities
A study testing HIFT for people with MRD in people with Mobility Limitation and Physical Disability, run by University of Kansas at 1 site in United States.
Trial 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.… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mobility Limitation, Physical Disability
- What is being tested?
- HIFT for people with MRD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 4 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Kansas
Lawrence, Kansas, 66045
Lyndsie Koon, PhD, 785-864-1611, lyndsiek@ku.edu
About this study
Official title: Exploring High-intensity Functional Training for People With Mobility-related Disability: A Pilot Study
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.
Read the 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.
- Conditions
- Mobility Limitation, Physical Disability
- Being tested
- HIFT for people with MRD
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFT for people with MRDOther
12-wk, 3x/week HIFT participation for individuals with MRD
| Study group | Role | What they receive |
|---|---|---|
| HIFT for People with MRD | Experimental | 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. Receives: Other: HIFT for people with MRD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline BMI at 13 weeks (post-intervention)
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.
Measured: Change from Baseline 3-site skinfolds at 13 weeks (post-intervention)
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.
Measured: Change from baseline strenghth at 13 weeks (post-intervention)
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.
Measured: Change from Baseline flexibility at 13 weeks (post-intervention)
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.
Measured: Change in Week 2 strength at week 12 of the intervention
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.
Measured: Change in baseline work capacity at weeks 10 and 12 of the intervention
Secondary outcomes (10)
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)
Measured: Change from Baseline perceived functional performance at 13 weeks (post-intervention)
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.
Measured: Change from Baseline QOL at 13 weeks (post-intervention)
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.
Measured: Change from Baseline life satisfaction at 13 weeks (post-intervention)
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)
Measured: Change from Baseline self-determination at 13 weeks (post-intervention)
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
Measured: Change from Baseline need satisfaction at 13 weeks (post-intervention)
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
Measured: Change from Baseline sense of community at 13 weeks (post-intervention)
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)
Measured: Change from Baseline shoulder pain at 13 weeks (post-intervention)
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).
Measured: Change from Baseline self-efficacy at 13 weeks (post-intervention)
Sleep
Sleep Disturbance Short Form (PROMIS Health Organization, 8b) will be used to assess self-report sleep quality in the past 7 days.
Measured: Change from Baseline sleep at 13 weeks (post-intervention)
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)
Measured: Change from Baseline perceived barriers at 13 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion4 Apr 2023 (estimated)
- Study completion4 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lyndsie Koon, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516030
- Sponsor's protocol ID
- 00148684
- Acronym
- Research GO
- Status last verified
- Aug 2022
- First submitted
- 29 Jul 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koon LM, Donnelly JE, Washburn R, Sherman JR, Kroeger MM, Swinburne Romine RE, Handlery R, Handlery K. Feasibility and preliminary functional, physical, and psychosocial effects of high-intensity functional training for adults with mobility disabilities. Pilot Feasibility Stud. 2025 Nov 27;11(1):152. doi: 10.1186/s40814-025-01725-2.
PubMed 41310847
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring High-intensity Functional Training for People With Mobility-related Disability: A Pilot Study
- ClinicalTrials.gov ID
- NCT05516030
- Acronym / sponsor ID
- Research GO / 00148684
- Conditions
- Mobility Limitation, Physical Disability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 4 Apr 2023 (estimated)
- Study completion
- 4 Apr 2023 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIFT for People with MRD | Experimental | Other: HIFT for people with MRD12-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIFT for people with MRD12-wk, 3x/week HIFT participation for individuals with MRD | Other | HIFT for People with MRD |
Primary outcome
Body Mass Index
Time frame: Change from Baseline BMI at 13 weeks (post-intervention)
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
Time frame: Change from Baseline 3-site skinfolds at 13 weeks (post-intervention)
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
Time frame: Change from baseline strenghth at 13 weeks (post-intervention)
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
Time frame: Change from Baseline flexibility at 13 weeks (post-intervention)
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
Time frame: Change in Week 2 strength at week 12 of the intervention
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
Time frame: Change in baseline work capacity at weeks 10 and 12 of the intervention
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.
10 secondary outcomes
Perceived Functional Performance
Time frame: Change from Baseline perceived functional performance at 13 weeks (post-intervention)
Perceived Quality of Life
Time frame: Change from Baseline QOL at 13 weeks (post-intervention)
Life Satisfaction
Time frame: Change from Baseline life satisfaction at 13 weeks (post-intervention)
Self-determination
Time frame: Change from Baseline self-determination at 13 weeks (post-intervention)
Psychological Need Satisfaction
Time frame: Change from Baseline need satisfaction at 13 weeks (post-intervention)
Sense of Community
Time frame: Change from Baseline sense of community at 13 weeks (post-intervention)
Shoulder Pain - wheelchair users only
Time frame: Change from Baseline shoulder pain at 13 weeks (post-intervention)
Exercise Self-efficacy
Time frame: Change from Baseline self-efficacy at 13 weeks (post-intervention)
Sleep
Time frame: Change from Baseline sleep at 13 weeks (post-intervention)
Barriers to Health
Time frame: Change from Baseline perceived barriers at 13 weeks (post-intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Derived from this study: PubMed 41310847Koon LM, Donnelly JE, Washburn R, Sherman JR, Kroeger MM, Swinburne Romine RE, Handlery R, Handlery K. Feasibility and preliminary functional, physical, and psychosocial effects of high-intensity functional training for adults with mobility disabilities. Pilot Feasibility Stud. 2025 Nov 27;11(1):152. doi: 10.1186/s40814-025-01725-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIFT for people with MRD in people with Mobility Limitation and Physical Disability, run by University of Kansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: Change from Baseline BMI at 13 weeks (post-intervention)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05516030, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.