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Completed

NCT Number: NCT07283510

Community-based Functional Fitness for Adults Aging With Mobility Disability

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

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas

Lawrence, Kansas, 66045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Fitness

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

Primary outcomes

  1. Change in Walking Speed as Assessed by the 10-Meter Walk Test (m/s)

    Time frame: From enrollment to the end of the intervention at 16-weeks

    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.

  2. Change in Aerobic Endurance as Assessed by the 2-Minute Step Test (steps)

    Time frame: From enrollment to the end of treatment at 16-weeks

    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.

  3. Change in Functional Mobility as Assessed by the Timed Up and Go Test (seconds)

    Time frame: From enrollment to the end of treatment at 16-weeks

    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.

  4. Change in Lower Extremity Functional Strength as Assessed by the Five Times Sit-to-Stand Test (seconds)

    Time frame: From enrollment to the end of treatment at 16-weeks

    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.

Secondary outcomes

  1. Change in Balance as Assessed by the Berg Balance Scale (score)

    Time frame: From enrollment to the end of treatment at 16-weeks

    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.

  2. Change in Postural Stability as Assessed by Postural Sway Measures (center of pressure displacement)

    Time frame: From enrollment to the end of treatment at 16-weeks

    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.

  3. Change in Handgrip Strength as Assessed by Jamar Smart Digital Hand Dynamometry (kg)

    Time frame: From enrollment to the end of treatment at 16-weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Kansas

Other

Collaborators

  • University of Kansas Medical Center

Registry information

Official study title

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

Acronym: AAIMLCOA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 15, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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