Functional Fitness for Overweight or Obese Adults with Mobility Disabilities

NCT05880966 | Active Not Recruiting

• 1 other identifier: 00043722
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Mobility Limitation; Overweight or Obesity; Physical Disability

Outcome Measures

Primary Outcomes (1)

• Weight

  Weight will be measured in duplicate using a portable calibrated, digital scale to the nearest 0.1 kg.

  Change from Baseline weight at 6 months (post-intervention)

Secondary Outcomes (23)

• Body Composition

  Change from Baseline body comp at 6 months (post-intervention)

• Waist Circumference

  Change from Baseline waist circumference at 6 months (post-intervention)

• Blood Pressure

  Change from Baseline blood pressure (diastolic and systolic) at 6 months (post-intervention)

• Glucose

  Change from Baseline fasting glucose at 6 months (post-intervention)

• Cholesterol

  Change from Baseline HDL cholesterol at 6 months (post-intervention)

Other Outcomes (4)

• Energy expenditure

  Week 12 of the intervention - one time exploratory measure

• Attendance

  Observed each week of the 24-week intervention

• Work Capacity

  Change in baseline work capacity (time; A1) at 12 weeks and 24 weeks of the intervention

Study Arms (1)

COBRE Single Group

EXPERIMENTAL

All participants will complete the 6-mos functional fitness interventions

Behavioral: Functional Fitness

Interventions

Functional Fitness BEHAVIORAL

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)

COBRE Single Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas: lead

Study Sites (1)

University of Kansas

Lawrence, Kansas, 66045, United States

Location

MeSH Terms

Conditions

Mobility Limitation; Overweight; Obesity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 30, 2023
• Study Start: April 17, 2023
• Primary Completion: March 30, 2025
• Study Completion: April 30, 2025
• Last Updated: March 10, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)