Clinical trial NCT05880966: Functional Fitness for Overweight or Obese Adults with Mobility Disabilities
Official title: Functional Training for Overweight/obese Adults with Mobility-related Disabilities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mobility Limitation
Overweight or Obesity
Physical Disability
Lead sponsor: University of Kansas
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Weight
timeFrame: Change from Baseline weight at 6 months (post-intervention)
Secondary outcomes:
measure: Body Composition
timeFrame: Change from Baseline body comp at 6 months (post-intervention)
measure: Waist Circumference
timeFrame: Change from Baseline waist circumference at 6 months (post-intervention)
measure: Blood Pressure
timeFrame: Change from Baseline blood pressure (diastolic and systolic) at 6 months (post-intervention)
measure: Glucose
timeFrame: Change from Baseline fasting glucose at 6 months (post-intervention)
measure: Cholesterol
timeFrame: Change from Baseline HDL cholesterol at 6 months (post-intervention)
measure: Triglycerides
timeFrame: Change from Baseline triglycerides at 6 months (post-intervention)
measure: Body Mass Index
timeFrame: Change from Baseline BMI at 6 months (post-intervention)
measure: Perceived Quality of Life
timeFrame: Change from Baseline QOL at 6 months (post-intervention)
measure: Perceived Life Satisfaction
timeFrame: Change from Baseline life satisfaction at 6 months (post-intervention)
measure: Flexibility
timeFrame: Change from Baseline flexibility at 6 months (post-intervention)
measure: Balance (Seated)
timeFrame: Change from baseline balance at 6 months (post-intervention)
measure: Balance (standing)
timeFrame: Change from baseline balance at 6 months (post-intervention)
measure: Strength
timeFrame: Change from baseline strength at 6 months (post-intervention)
measure: Mobility
timeFrame: Change from baseline mobility at 6 months (post-intervention)
measure: Sense of Community
timeFrame: Change from baseline sense of community at 6 months (post-intervention)
measure: Shoulder Pain - manual wheelchair users only
timeFrame: Change from baseline shoulder pain at 6 months (post-intervention)
measure: Exercise self-efficacy
timeFrame: Change from baseline self-efficacy at 6 months (post-intervention)
measure: Sleep
timeFrame: Change from baseline sleep at 6 months (post-intervention)
measure: Barriers to Health
timeFrame: Change from baseline perceived barriers at 6 months (post-intervention)
measure: Psychological Need Satisfaction
timeFrame: Change from baseline perceived need satisfaction at 6 months (post-intervention)
measure: Self-determination
timeFrame: Change from baseline perceived need self-determination at 6 months (post-intervention)
measure: Perceived Functional Performance
timeFrame: Change from baseline perceived performance in occupational activities at 6 months (post-intervention)
measure: Perceived Functional Performance
timeFrame: Change from baseline perceived satisfaction in performing occupational activities at 6 months (post-intervention)
Other outcomes:
measure: Energy expenditure
timeFrame: Week 12 of the intervention - one time exploratory measure
measure: Attendance
timeFrame: Observed each week of the 24-week intervention
measure: Work Capacity
timeFrame: Change in baseline work capacity (time; A1) at 12 weeks and 24 weeks of the intervention
measure: Work Capacity
timeFrame: Change in baseline work capacity (reps; A2) at 12 weeks and 24 weeks of the intervention
Locations:
city: Lawrence
country: United States
facility: University of Kansas
state: Kansas
Study officials:
References: