Community-based Functional Fitness for Adults Aging With Mobility Disability (AAIMLCOA)

Exploring the Effects of a Community-based Functional Fitness Program on Physical Function Among Adults Aging With Mobility Disability: A Pilot Study

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

Study Overview

• Status: Completed
• Conditions: Older Adults; Mobility Disability
• Intervention / Treatment: Behavioral: Functional Fitness

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lawrence, Kansas, United States, 66045
      • University of Kansas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: In-person Functional Fitness Arm; In-person, thrice weekly, 16-week functional fitness arm took place at community-based functional fitness affiliate locations

Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Walking Speed as Assessed by the 10-Meter Walk Test (m/s)	Walking speed will be assessed using the 10-meter walk test. Participants will be instructed to walk a marked 10-meter distance at a comfortable pace. Walking speed will be calculated in meters per second, with higher values indicating faster walking speed and better mobility.	From enrollment to the end of the intervention at 16-weeks
Change in Aerobic Endurance as Assessed by the 2-Minute Step Test (steps)	Aerobic endurance will be assessed using the 2-minute step test. The total number of steps completed within two minutes will be recorded, with higher step counts indicating greater aerobic endurance.	From enrollment to the end of treatment at 16-weeks
Change in Functional Mobility as Assessed by the Timed Up and Go Test (seconds)	Functional mobility will be assessed using the Timed Up and Go test. Time (in seconds) required to stand from a seated position, walk a standardized distance, turn, return, and sit will be recorded. Shorter completion times indicate better functional mobility.	From enrollment to the end of treatment at 16-weeks
Change in Lower Extremity Functional Strength as Assessed by the Five Times Sit-to-Stand Test (seconds)	Lower extremity functional strength will be assessed using the Five Times Sit-to-Stand test. Time (in seconds) required to complete five repeated sit-to-stand transitions will be recorded, with shorter times indicating greater functional strength.	From enrollment to the end of treatment at 16-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Balance as Assessed by the Berg Balance Scale (score)	Balance will be assessed using the Berg Balance Scale, a 14-item performance-based measure of static and dynamic balance. Total scores range from 0 to 56, with higher scores indicating better balance performance.	From enrollment to the end of treatment at 16-weeks
Change in Postural Stability as Assessed by Postural Sway Measures (center of pressure displacement)	Postural stability will be assessed by quantifying postural sway during quiet standing. Measures will include displacement of the center of pressure over a fixed period, with greater sway (in degrees) indicating poorer postural stability.	From enrollment to the end of treatment at 16-weeks
Change in Handgrip Strength as Assessed by Jamar Smart Digital Hand Dynamometry (kg)	Grip strength of both the dominant and non-dominant hands will be assessed using a Jamar Smart Digital hand dynamometer. Peak grip force will be recorded in kilograms, with higher values indicating greater upper extremity strength.	From enrollment to the end of treatment at 16-weeks

Collaborators and Investigators

• Sponsor: University of Kansas
• Collaborators: University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Actual): November 20, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: April 15, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Estimated): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Older Adults; Functional Fitness; Mobility Disability; Community-based Exercise; Aging with Disability
• Other Study ID Numbers: GR17636

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We are still evaluating the feasibility of sharing individual participant data (IPD) based on privacy considerations, data use agreements, and input from our institutional review board. We recognize the value of data sharing for advancing research and plan to assess appropriate mechanisms to ensure responsible access to de-identified IPD, if permitted.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No