Mobility DisabilityAAIMLCOANCT07283510
Community-based Functional Fitness for Adults Aging With Mobility Disability
A study testing Functional Fitness in people with Mobility Disability and Older Adults, run by University of Kansas at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mobility Disability, Older Adults
- What is being tested?
- Functional Fitness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to utilize reliable transportation to travel to and from the fitness facility three times per week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- Functional Fitness
- Keywords
- Functional Fitness, Mobility Disability, Aging with Disability, Older Adults, Community-based Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional FitnessBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| In-person Functional Fitness Arm | Experimental | In-person, thrice weekly, 16-week functional fitness arm took place at community-based functional fitness affiliate locations Receives: Behavioral: Functional Fitness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 16-weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 16-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start17 Oct 2023
- Primary completion20 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas Medical Center
- Responsible party
- Principal investigator, Lyndsie Koon, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283510
- Sponsor's protocol ID
- GR17636
- Acronym
- AAIMLCOA
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of a Community-based Functional Fitness Program on Physical Function Among Adults Aging With Mobility Disability: A Pilot Study
- ClinicalTrials.gov ID
- NCT07283510
- Acronym / sponsor ID
- AAIMLCOA / GR17636
- Conditions
- Mobility Disability, Older Adults
- Keywords
- Functional Fitness, Mobility Disability, Aging with Disability, Older Adults, Community-based Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- University of Kansas Medical Center
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In-person Functional Fitness Arm | Experimental | Behavioral: Functional FitnessIn-person, thrice weekly, 16-week functional fitness arm took place at community-based functional fitness affiliate locations |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Inability to utilize reliable transportation to travel to and from the fitness facility three times per week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional FitnessLocation/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 | Behavioural | In-person Functional Fitness Arm |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
Change in Balance as Assessed by the Berg Balance Scale (score)
Time frame: From enrollment to the end of treatment at 16-weeks
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Fitness in people with Mobility Disability and Older Adults, run by University of Kansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.