NCT05880966: COBRE Pilot

Functional Fitness for Overweight or Obese Adults with Mobility Disabilities

Active, enrolled NA Last updated 10 March 2025

What this trial tests

NA trial testing Functional Fitness in Mobility Limitation in 25 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

17 April 2023

Primary endpoint
30 March 2025

30 April 2025

Quick facts

Lead sponsor	University of Kansas
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	25
Start date	17 April 2023
Primary completion	30 March 2025
Estimated completion	30 April 2025
Sites	1 location across United States

Drugs / interventions tested

• Functional Fitness

Conditions studied

• Mobility Limitation — all drugs for Mobility Limitation →
• Overweight or Obesity — all drugs for Overweight or Obesity →
• Physical Disability — all drugs for Physical Disability →

Sponsor

University of Kansas

Who can join

Adults 18 to 64, any sex, with Mobility Limitation or Overweight or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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%). 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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.