Community-based Functional Fitness for Adults Aging With Mobility Disability

NCT ID: NCT07283510

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-17
• Study Completion Date: 2024-12-01

Brief Summary

Evaluate the feasibility and potential effectiveness of a 12-week, high-intensity functional training (HIFT) intervention on frailty in older adults (60+) with mobility disabilities (MD) who are ambulatory

Detailed Description

The purpose of this pilot study is to determine the feasibility and effectiveness of an adaptive and inclusive community-based exercise intervention targeting parameters associated with the development of frailty in older adults with a mobility disability (MD). Adults aging with MD differ from those aging into MD, as this population is managing an original disability acquired earlier in life with secondary conditions, in addition to age-related changes. The interactive effects of aging and disability may result in greater susceptibility to frailty, defined as a state of vulnerability that increases risk for adverse health outcomes. Exercise is a potentially viable option for supporting functional health factors that contribute to frailty, as exercise participation has been associated with improvements in multiple functional outcomes (e.g., balance, strength) among people with MD, to a greater extent than other health outcomes (e.g., mental, metabolic health). Many exercise trials demonstrating promising results are conducted in laboratory or clinical settings, where long-term participation is often unsustainable and transferability to community settings is limited. Therefore, the investigators propose to evaluate the feasibility and effects of a community-based, adaptable, and inclusive exercise program known as Functional Fitness (FF) for adults aging with MD. FF is one of the fastest-growing fitness trends and incorporates movement patterns that simulate everyday activities important for individuals with MD, including transferring, picking up an object from a seated position, and ambulating without supports.

The investigators will conduct a single-arm pilot trial of a 16-week community-based Functional Fitness (FF) intervention (three 60-minute sessions per week) in 12 older adults (aged 60 years and older) with a permanent mobility disability. The study will address the following aims:

Aim 1. Feasibility of the FF intervention will be assessed based on participant recruitment, session attendance, retention, and completion of all outcome assessments. Semi-structured exit interviews will be conducted with all participants to elicit feedback on suggested intervention improvements, perceptions of intervention length and frequency, satisfaction with instructors, exercise facilities, and session content, as well as challenges related to intervention compliance.

Aim 2. Effectiveness of the 16-week intervention will be evaluated based on changes in functional outcomes independently associated with frailty, including mobility, balance, strength, and psychosocial outcomes. FF will be implemented through an existing community program (Adaptive Athletes in Motion) that has served the disability community for more than five years by providing scholarship-based Functional Fitness programming to individuals with a range of disability types, primarily mobility-related disabilities. Given its prevalence and inclusive design, FF provides a framework for widespread adoption, implementation, and maintenance of exercise programming for older adults with MD. Results from the proposed trial will generate preliminary evidence regarding the feasibility of FF for adults aging with MD and provide novel empirical data on the program's potential effects on frailty-related outcomes in an understudied population at increased risk for loss of functional independence due to the intersection of aging and disability.

Conditions

Mobility Disability; Older Adults

Keywords

Functional Fitness; Mobility Disability; Aging with Disability; Older Adults; Community-based Exercise

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

In-person Functional Fitness Arm

In-person, thrice weekly, 16-week functional fitness arm took place at community-based functional fitness affiliate locations

Group Type: EXPERIMENTAL

Functional Fitness

Intervention Type: BEHAVIORAL

Location/availability: To increase access, FF sessions will be available at 3 facilities located in the greater Kansas City area. Each facility has accessible space, equipment, and certified Adaptive and Inclusive FF trainers to deliver the intervention. Sessions will be capped at 10 participants and led by a minimum of two certified trainers. Acclimation: Prior to initiating the intervention, participants will complete two acclimation sessions to learn the basic FF movements adapted to their abilities and required safety protocols. FF session frequency: Participants will be asked to attend 3 - 60 min. group sessions/wk. over 16 wks. (48 total sessions). FF session content: Each session will include a warm-up (\~15 min.) FF (\~30 min) and a cool down (\~15 min). Sessions will be standardized; however, all aspects of the session (movements, load) will be adapted to individual capabilities. FF prescriptions for each session and participant adaptations will be documented

Interventions

Functional Fitness

Location/availability: To increase access, FF sessions will be available at 3 facilities located in the greater Kansas City area. Each facility has accessible space, equipment, and certified Adaptive and Inclusive FF trainers to deliver the intervention. Sessions will be capped at 10 participants and led by a minimum of two certified trainers. Acclimation: Prior to initiating the intervention, participants will complete two acclimation sessions to learn the basic FF movements adapted to their abilities and required safety protocols. FF session frequency: Participants will be asked to attend 3 - 60 min. group sessions/wk. over 16 wks. (48 total sessions). FF session content: Each session will include a warm-up (\~15 min.) FF (\~30 min) and a cool down (\~15 min). Sessions will be standardized; however, all aspects of the session (movements, load) will be adapted to individual capabilities. FF prescriptions for each session and participant adaptations will be documented

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Aged 60 years or older

Presence of a permanent mobility disability (duration of at least 1 year)

Ambulatory (does not use a manual or power wheelchair for mobility)

Not currently participating in a structured exercise program

No significant health impairment that would contraindicate participation in Functional Fitness, as confirmed by a primary care provider

Ability to serve as one's own guardian and provide informed consent

Exclusion Criteria

Inability to utilize reliable transportation to travel to and from the fitness facility three times per week

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: collaborator

University of Kansas

OTHER

Sponsor Role: lead

Responsible Party

Lyndsie Koon

Assistant Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Kansas

Lawrence, Kansas, United States

Countries

United States

Other Identifiers

GR17636

Identifier Type: -

Identifier Source: org_study_id