25 Participants Needed

Functional Fitness for Obesity with Limited Mobility

(COBRE Pilot Trial)

Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Kansas
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for adults aged 18-64 with mobility-related disabilities who are overweight or obese (BMI of 24-45). Participants must not have previously joined a functional fitness program and need a doctor's approval to exercise. They should be able to make decisions for themselves.

Inclusion Criteria

My doctor agrees I can safely exercise.
Body mass index between 24-45
Never been a part of a functional fitness program before
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a High-Intensity Functional Training (HIFT) intervention, consisting of 60-minute sessions, 3 days per week, for 6 months

24 weeks
72 sessions (in-person)

Follow-up

Participants are monitored for changes in weight, body composition, and metabolic syndrome components after the intervention

4 weeks

Treatment Details

Interventions

  • Functional Fitness
Trial Overview The study tests if high-intensity functional training (HIFT) can help manage weight and improve health in adults with mobility disabilities. It involves exercising three times a week for six months, aiming to see changes in body composition and metabolic health.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: COBRE Single GroupExperimental Treatment1 Intervention
All participants will complete the 6-mos functional fitness interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Kansas

Lead Sponsor

Trials
157
Recruited
332,000+