Mobility LimitationCOBRE PilotNCT05880966
Functional Fitness for Overweight or Obese Adults With Mobility Disabilities
A study testing Functional Fitness in people with Mobility Limitation and Overweight or Obesity, run by University of Kansas at 1 site in United States.
Trial summary
Over 64 million people in the U.S. have a permanent disability, with mobility-related disability (MRD) representing the most prevalent disability type (13.7%). Adults with MRD are 66% more likely to be overweight or obese than their non-disabled peers. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Mobility Limitation, Overweight or Obesity, Physical Disability
- What is being tested?
- Functional Fitness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2023to 30 Apr 2025
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-64 years of age
- Have a permanent disability that affects mobility (1 year +);
- Body mass index between 24-52
- Never been a part of a functional fitness program before
- Have 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 or 65 years or older
- Have a disability that was acquired within 1 year of starting the study or has a non-permanent mobility limitation (e.g., broken arm);
- Have a body mass index less than 24 or greater than 52
- 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.
About this study
Official title: Functional Training for Overweight/Obese Adults With Mobility-related Disabilities
Over 64 million people in the U.S. have a permanent disability, with mobility-related disability (MRD) representing the most prevalent disability type (13.7%). Adults with MRD are 66% more likely to be overweight or obese than their non-disabled peers. Exercise in adults with MRD is important for weight management and is associated with improvements in obesity-related health conditions including hypertension, hyperlipidemia, insulin processing/sensitivity, etc. However, over half (57%) of adults with MRD do not exercise, while 22% engage in exercise of insufficient duration or intensity to obtain health benefits. Adults with MRD face numerous barriers to participation in community-based exercise, and exercise is frequently limited to short-term referrals for outpatient physical and/or occupational therapy. High-intensity functional training (HIFT) represents a potentially effective strategy for community-based exercise to support body weight and obesity-related health conditions, in addition to improving physical function and aspects of psychosocial health for people with disabilities. Preliminary evidence supports the effectiveness of HIFT to improve body composition, cardiovascular and muscular fitness, insulin processing and insulin sensitivity in non-disabled adults who are overweight/obese. To date, no study has systematically evaluated the feasibility or effectiveness of a community-based HIFT intervention for improving obesity-related health outcomes in overweight/obese adults with MRD. Thus, the proposed study will implement a 6-mo. pilot trial to evaluate the feasibility and potential effectiveness of a HIFT intervention (60 min sessions/3 days/wk.) in 25 adults with MRD and overweight/obesity.
This study will address the following aims:
Read more
Aim 1: Evaluate the intervention feasibility based on participant recruitment, session attendance, retention, outcome assessment completion, and the results of semi-structured exit interviews to obtain information regarding experience and overall satisfaction with the intervention.
Aim 2: Evaluate changes (baseline - 6 mos.) in weight and fat-mass/fat-free mass, and components of the metabolic syndrome (waist circumference, blood pressure, HDL-cholesterol, triglycerides, fasting glucose).
Read the detailed description
Over 64 million people in the U.S. have a permanent disability, with mobility-related disability (MRD) representing the most prevalent disability type (13.7%). The occurrence of chronic conditions including obesity, diabetes, hypertension, and hyperlipidemia are significantly higher in adults with disabilities compared with non-disabled adults. Adults with MRD are 66% more likely to be overweight or obese than their non-disabled peers. Exercise in adults with MRD is important for weight management and is associated with improvements in obesity-related health conditions including hypertension, hyperlipidemia, insulin processing/sensitivity, etc. However, over half (57%) of adults with MRD do not exercise, while 22% engage in exercise of insufficient duration or intensity to obtain health benefits. Adults with MRD face numerous intrapersonal, environmental, and financial barriers to participation in community-based exercise, and exercise is frequently limited to short-term referrals for outpatient physical and/or occupational therapy. While effective, these clinical settings do not provide a long-term strategy for the delivery of exercise programs to the general population of adults with MRD.
High-intensity functional training (HIFT) represents a potentially effective strategy for community-based exercise to support body weight and obesity-related health conditions, in addition to improving physical function and aspects of psychosocial health for people with disabilities. HIFT incorporates multiple exercise modalities and constantly varied functional movement patterns designed to simulate daily activities (e.g., sit-to-stand, transferring). The variety of functional movements offered by HIFT may be more enjoyable and result in better long-term adherence compared with traditional single mode continuous aerobic exercise such as stationary biking, arm cycling, or treadmill walking/running. Preliminary evidence supports the effectiveness of HIFT to improve body composition, cardiovascular and muscular fitness, insulin processing and insulin sensitivity in non-disabled adults who are overweight/obese. The limited available data relative to HIFT interventions in adults with MRD provides some support for the feasibility and potential effectiveness of HIFT in adults with MRD including high retention rates, positive intervention experiences, improved functional capacity and confidence in performing daily movements. However, this data is based on unpowered pilot studies and unpublished these/dissertations with poor descriptions of the HIFT interventions, and thus should be cautiously interpreted. To date, no study has systematically evaluated the feasibility or effectiveness of a community-based HIFT intervention for improving obesity-related health outcomes in overweight/obese adults with MRD. Thus, Thus, the proposed study will implement a 6-mo. pilot trial to evaluate the feasibility and potential effectiveness of a HIFT intervention (60 min sessions/3 days/wk.) in 25 adults with MRD and overweight/obesity. The intervention will be conducted at two community-based facilities in greater Kansas City that have been conducting HIFT sessions for adults with disabilities for over three years. HIFT sessions will be delivered by instructors certified by the Adaptive Training Academy (ATA), a non-profit organization, which provides training in adapting and conducting safe HIFT sessions for people with disabilities. This study will address the following aims:
Aim 1: Evaluate the intervention feasibility based on participant recruitment, session attendance, retention, outcome assessment completion, and the results of semi-structured exit interviews to obtain information regarding study improvements, perceptions of the length/frequency of the intervention, satisfaction with instructors, exercise facilities, session content, difficulties with compliance, and overall satisfaction with the intervention.
Aim 2: Evaluate changes (baseline - 6 mos.) in weight (primary outcome), and secondary outcomes including fat-mass/fat-free mass, and components of the metabolic syndrome (waist circumference, blood pressure, HDL-cholesterol, triglycerides, fasting glucose). Energy expenditure will also be measured during HIFT sessions using portable indirect calorimetry.
Results from this study will inform the development of an NIH-R01 application to conduct an adequately powered, randomized trial in overweight/obese adults with MRD to evaluate the effectiveness of HIFT over a longer time frame (i.e., 12 mos.), on the obesity-related outcomes proposed for this study plus additional health and functional related outcomes. If ultimately shown to be effective, the physical infrastructure available in the over 5,000 HIFT affiliates across the country would provide the framework for widespread adoption, implementation, and maintenance of inclusive HIFT programs for adults with MRD.
- Being tested
- Functional Fitness
- Medical subject headings
- Mobility Limitation, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional FitnessBehavioural
Six month, thrice weekly functional fitness sessions will include a warm-up (15 minutes), skill or strength work (30 minutes) and a cool down (15 minutes)
| Study group | Role | What they receive |
|---|---|---|
| COBRE Single Group | Experimental | All participants will complete the 6-mos functional fitness interventions Receives: Behavioral: Functional Fitness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight will be measured in duplicate using a portable calibrated, digital scale to the nearest 0.1 kg.
Measured: Change from Baseline weight at 6 months (post-intervention)
Secondary outcomes (23)
Body Composition
Fat free and fat-mass Dual Energy X-ray Absorptiometry (DEXA) will be performed at the KU Edwards campus to determine the fat-free mass, fat mass, and body fat percentage (Prodigy Advance Plus, GE, Madison, WI)
Measured: Change from Baseline body comp at 6 months (post-intervention)
Waist Circumference
Waist circumference will be assessed with a calibrated tape. For those unable to stand, waist circumference will be measured in the seated position at the umbilicus. Three measurements will be obtained with the outcome recorded as the average of the closest 2 measures.
Measured: Change from Baseline waist circumference at 6 months (post-intervention)
Blood Pressure
Blood pressure will be obtained with an automated sphygmomanometer (DinaMap ProCare 100, General Electric) using the NHANES blood pressure protocol and recommendations of the American Heart Association.
Measured: Change from Baseline blood pressure (diastolic and systolic) at 6 months (post-intervention)
Glucose
Fasting glucose will be assessed following finger prick blood draw with 8 hours prior of fasting
Measured: Change from Baseline fasting glucose at 6 months (post-intervention)
Cholesterol
HDL Cholestserol will be assessed following finger prick blood draw
Measured: Change from Baseline HDL cholesterol at 6 months (post-intervention)
Triglycerides
Triglycerides will be assessed following finger prick blood draw
Measured: Change from Baseline triglycerides at 6 months (post-intervention)
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 6 months (post-intervention)
Perceived Quality of Life
World Health Organization Quality of Life an internationally recognized and established short measure assessing quality of life. There are 26 items on this survey, with a minimum value of 26, and a maximum value of 130. The higher the score, the higher the perceived quality of life.
Measured: Change from Baseline QOL at 6 months (post-intervention)
Perceived Life Satisfaction
the Satisfaction with Life Questionnaire will be used as an additional assessment of well-being. There are five items on this survey, with a minimum score of 5 and a maximum score of 35, higher scores indicate higher satisfaction with life.
Measured: Change from Baseline life satisfaction at 6 months (post-intervention)
Flexibility
Back Scratch Test - 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 6 months (post-intervention)
Balance (Seated)
Participants who are non-ambulatory participants will complete the Function in Sitting Test. Minimum score is 0 and maximum score is 56, where higher scores indicate better balance.
Measured: Change from baseline balance at 6 months (post-intervention)
Balance (standing)
Participants who are ambulatory will complete the Berg Balance Scale test. Minimum score is 0 and maximum score is 56, where higher scores indicate better balance.
Measured: Change from baseline balance at 6 months (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 strength at 6 months (post-intervention)
Mobility
participants who are ambulatory will complete the 6-minute walking test and the 10-meter walking speed test, both of which can be completed with the help of an assistive device as needed. Distance covered during the 6-minute walking test will be calculated with meters, and average walking speed will be calculated as miles per hour. Participants who are non-ambulatory will complete a 6-minute push test and the Timed Forward Wheeling (23-meters) test. Distance covered during the 6-minute push test will be converted to meters, and timed forward wheeling will assess average speed calculated as miles per hour.
Measured: Change from baseline mobility at 6 months (post-intervention)
Sense of Community
The Sense of Community Scale will be used to assess perceptions of community among the administration, social spaces, other members and competition. Minimum score is 18 and maximum score is 72, where higher scores indicate greater sense of community.
Measured: Change from baseline sense of community at 6 months (post-intervention)
Shoulder Pain - manual wheelchair users only
he Wheelchair User's Shoulder Pain Index will be used to assess self-report changes in shoulder pain during daily functional activities with a 10-point visual analog scale. Minimum score is 15 and maximum score is 150, where higher scores indicate greater pain.
Measured: Change from baseline shoulder pain at 6 months (post-intervention)
Exercise self-efficacy
28-item Self-Related Abilities for Health Practices Scale to assess self-efficacy scores regarding exercise, nutrition, health practices and psychological well-being. Minimum score is 0 and maximum score is 112, where higher scores indicate greater exercise self-efficacy.
Measured: Change from baseline self-efficacy at 6 months (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. Minimum score is 8 and maximum score is 40, where lower scores indicate better sleep.
Measured: Change from baseline sleep at 6 months (post-intervention)
Barriers to Health
The 16-item Barriers to Health Adapted for People with Disabilities will assess participant self-report of perceived motivational and external barrier to exercise. Minimum score is 18 and maximum score is 72, where higher scores indicate greater perceived barriers to health promoting activities.
Measured: Change from baseline perceived barriers at 6 months (post-intervention)
Psychological Need Satisfaction
The Psychological Need Satisfaction in Exercise Questionnaire will be used to assess need satisfaction within the functional fitness environment. Include three subscale autonomy, competence, and relatedness. Minimum score is 18 and maximum score is 108, where higher scores indicate better need satisfaction.
Measured: Change from baseline perceived need satisfaction at 6 months (post-intervention)
Self-determination
Behavioral Regulation in Exercise Questionnaire 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). Minimum score is 19 and maximum score is 95, where higher scores indicate more self-determined motives for exercise.
Measured: Change from baseline perceived need self-determination at 6 months (post-intervention)
Perceived Functional Performance
The Canadian Occupational Therapy Measure 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 for each of these performance areas. The client's ratings of performance ability will be used to calculate the client's baseline average occupational performance ability. Baseline average performance scores are then used to determine if a client's occupational performance improvements occur over time. Range of scoring is 1-10, where higher scores indicate greater perceived performance.
Measured: Change from baseline perceived performance in occupational activities at 6 months (post-intervention)
Perceived Functional Performance
The Canadian Occupational Therapy Measure 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 satisfaction of their ability for each of these performance areas. The client's ratings satisfaction will be used to calculate the client's baseline average occupational satisfaction of their ability. Baseline average satisfaction scores are then used to determine if a client's occupational performance improvements occur over time. Range of scoring is 1-10, where higher scores indicate greater perceived satisfaction.
Measured: Change from baseline perceived satisfaction in performing occupational activities at 6 months (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start17 Apr 2023
- Primary completion30 Mar 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880966
- Sponsor's protocol ID
- 00043722
- Acronym
- COBRE Pilot
- Status last verified
- Jun 2024
- First submitted
- 17 Apr 2023
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Training for Overweight/Obese Adults With Mobility-related Disabilities
- ClinicalTrials.gov ID
- NCT05880966
- Acronym / sponsor ID
- COBRE Pilot / 00043722
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 30 May 2023 (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.
Over 64 million people in the U.S. have a permanent disability, with mobility-related disability (MRD) representing the most prevalent disability type (13.7%). Adults with MRD are 66% more likely to be overweight or obese than their non-disabled peers. Exercise in adults with MRD is important for weight management and is associated with improvements in obesity-related health conditions including hypertension, hyperlipidemia, insulin processing/sensitivity, etc. However, over half (57%) of adults with MRD do not exercise, while 22% engage in exercise of insufficient duration or intensity to obtain health benefits. Adults with MRD face numerous barriers to participation in community-based exercise, and exercise is frequently limited to short-term referrals for outpatient physical and/or occupational therapy. High-intensity functional training (HIFT) represents a potentially effective strategy for community-based exercise to support body weight and obesity-related health conditions, in addition to improving physical function and aspects of psychosocial health for people with disabilities. Preliminary evidence supports the effectiveness of HIFT to improve body composition, cardiovascular and muscular fitness, insulin processing and insulin sensitivity in non-disabled adults who are overweight/obese. To date, no study has systematically evaluated the feasibility or effectiveness of a community-based HIFT intervention for improving obesity-related health outcomes in overweight/obese adults with MRD. Thus, the proposed study will implement a 6-mo. pilot trial to evaluate the feasibility and potential effectiveness of a HIFT intervention (60 min sessions/3 days/wk.) in 25 adults with MRD and overweight/obesity.
This study will address the following aims:
Aim 1: Evaluate the intervention feasibility based on participant recruitment, session attendance, retention, outcome assessment completion, and the results of semi-structured exit interviews to obtain information regarding experience and overall satisfaction with the intervention.
Aim 2: Evaluate changes (baseline - 6 mos.) in weight and fat-mass/fat-free mass, and components of the metabolic syndrome (waist circumference, blood pressure, HDL-cholesterol, triglycerides, fasting glucose).
Detailed description
Over 64 million people in the U.S. have a permanent disability, with mobility-related disability (MRD) representing the most prevalent disability type (13.7%). The occurrence of chronic conditions including obesity, diabetes, hypertension, and hyperlipidemia are significantly higher in adults with disabilities compared with non-disabled adults. Adults with MRD are 66% more likely to be overweight or obese than their non-disabled peers. Exercise in adults with MRD is important for weight management and is associated with improvements in obesity-related health conditions including hypertension, hyperlipidemia, insulin processing/sensitivity, etc. However, over half (57%) of adults with MRD do not exercise, while 22% engage in exercise of insufficient duration or intensity to obtain health benefits. Adults with MRD face numerous intrapersonal, environmental, and financial barriers to participation in community-based exercise, and exercise is frequently limited to short-term referrals for outpatient physical and/or occupational therapy. While effective, these clinical settings do not provide a long-term strategy for the delivery of exercise programs to the general population of adults with MRD.
High-intensity functional training (HIFT) represents a potentially effective strategy for community-based exercise to support body weight and obesity-related health conditions, in addition to improving physical function and aspects of psychosocial health for people with disabilities. HIFT incorporates multiple exercise modalities and constantly varied functional movement patterns designed to simulate daily activities (e.g., sit-to-stand, transferring). The variety of functional movements offered by HIFT may be more enjoyable and result in better long-term adherence compared with traditional single mode continuous aerobic exercise such as stationary biking, arm cycling, or treadmill walking/running. Preliminary evidence supports the effectiveness of HIFT to improve body composition, cardiovascular and muscular fitness, insulin processing and insulin sensitivity in non-disabled adults who are overweight/obese. The limited available data relative to HIFT interventions in adults with MRD provides some support for the feasibility and potential effectiveness of HIFT in adults with MRD including high retention rates, positive intervention experiences, improved functional capacity and confidence in performing daily movements. However, this data is based on unpowered pilot studies and unpublished these/dissertations with poor descriptions of the HIFT interventions, and thus should be cautiously interpreted. To date, no study has systematically evaluated the feasibility or effectiveness of a community-based HIFT intervention for improving obesity-related health outcomes in overweight/obese adults with MRD. Thus, Thus, the proposed study will implement a 6-mo. pilot trial to evaluate the feasibility and potential effectiveness of a HIFT intervention (60 min sessions/3 days/wk.) in 25 adults with MRD and overweight/obesity. The intervention will be conducted at two community-based facilities in greater Kansas City that have been conducting HIFT sessions for adults with disabilities for over three years. HIFT sessions will be delivered by instructors certified by the Adaptive Training Academy (ATA), a non-profit organization, which provides training in adapting and conducting safe HIFT sessions for people with disabilities. This study will address the following aims:
Aim 1: Evaluate the intervention feasibility based on participant recruitment, session attendance, retention, outcome assessment completion, and the results of semi-structured exit interviews to obtain information regarding study improvements, perceptions of the length/frequency of the intervention, satisfaction with instructors, exercise facilities, session content, difficulties with compliance, and overall satisfaction with the intervention.
Aim 2: Evaluate changes (baseline - 6 mos.) in weight (primary outcome), and secondary outcomes including fat-mass/fat-free mass, and components of the metabolic syndrome (waist circumference, blood pressure, HDL-cholesterol, triglycerides, fasting glucose). Energy expenditure will also be measured during HIFT sessions using portable indirect calorimetry.
Results from this study will inform the development of an NIH-R01 application to conduct an adequately powered, randomized trial in overweight/obese adults with MRD to evaluate the effectiveness of HIFT over a longer time frame (i.e., 12 mos.), on the obesity-related outcomes proposed for this study plus additional health and functional related outcomes. If ultimately shown to be effective, the physical infrastructure available in the over 5,000 HIFT affiliates across the country would provide the framework for widespread adoption, implementation, and maintenance of inclusive HIFT programs for adults with MRD.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COBRE Single Group | Experimental | Behavioral: Functional FitnessAll participants will complete the 6-mos functional fitness interventions |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-64 years of age
- Have a permanent disability that affects mobility (1 year +);
- Body mass index between 24-52
- Never been a part of a functional fitness program before
- Have no significant health impairment that would contraindicate exercise (physician clearance required)
Key exclusion criteria (6 listed)
- Younger than 18 years of age or 65 years or older
- Have a disability that was acquired within 1 year of starting the study or has a non-permanent mobility limitation (e.g., broken arm);
- Have a body mass index less than 24 or greater than 52
- Has previously been involved in functional fitness
- Unable to obtain physician clearance
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 |
|---|---|---|
| Functional FitnessSix month, thrice weekly functional fitness sessions will include a warm-up (15 minutes), skill or strength work (30 minutes) and a cool down (15 minutes) | Behavioural | COBRE Single Group |
Primary outcome
Weight
Time frame: Change from Baseline weight at 6 months (post-intervention)
Weight will be measured in duplicate using a portable calibrated, digital scale to the nearest 0.1 kg.
23 secondary outcomes
Body Composition
Time frame: Change from Baseline body comp at 6 months (post-intervention)
Waist Circumference
Time frame: Change from Baseline waist circumference at 6 months (post-intervention)
Blood Pressure
Time frame: Change from Baseline blood pressure (diastolic and systolic) at 6 months (post-intervention)
Glucose
Time frame: Change from Baseline fasting glucose at 6 months (post-intervention)
Cholesterol
Time frame: Change from Baseline HDL cholesterol at 6 months (post-intervention)
Triglycerides
Time frame: Change from Baseline triglycerides at 6 months (post-intervention)
Body Mass Index
Time frame: Change from Baseline BMI at 6 months (post-intervention)
Perceived Quality of Life
Time frame: Change from Baseline QOL at 6 months (post-intervention)
Perceived Life Satisfaction
Time frame: Change from Baseline life satisfaction at 6 months (post-intervention)
Flexibility
Time frame: Change from Baseline flexibility at 6 months (post-intervention)
Balance (Seated)
Time frame: Change from baseline balance at 6 months (post-intervention)
Balance (standing)
Time frame: Change from baseline balance at 6 months (post-intervention)
Strength
Time frame: Change from baseline strength at 6 months (post-intervention)
Mobility
Time frame: Change from baseline mobility at 6 months (post-intervention)
Sense of Community
Time frame: Change from baseline sense of community at 6 months (post-intervention)
Shoulder Pain - manual wheelchair users only
Time frame: Change from baseline shoulder pain at 6 months (post-intervention)
Exercise self-efficacy
Time frame: Change from baseline self-efficacy at 6 months (post-intervention)
Sleep
Time frame: Change from baseline sleep at 6 months (post-intervention)
Barriers to Health
Time frame: Change from baseline perceived barriers at 6 months (post-intervention)
Psychological Need Satisfaction
Time frame: Change from baseline perceived need satisfaction at 6 months (post-intervention)
Self-determination
Time frame: Change from baseline perceived need self-determination at 6 months (post-intervention)
Perceived Functional Performance
Time frame: Change from baseline perceived performance in occupational activities at 6 months (post-intervention)
Perceived Functional Performance
Time frame: Change from baseline perceived satisfaction in performing occupational activities at 6 months (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Fitness in people with Mobility Limitation and Overweight or Obesity, 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 12 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Change from Baseline weight at 6 months (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.