Community-based Functional Fitness for Adults Aging With Mobility Disability

NCT07283510 | Completed

• 1 other identifier: GR17636
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Conditions

Mobility Disability; Older Adults

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

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

  From enrollment to the end of treatment at 16-weeks

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

  From enrollment to the end of treatment at 16-weeks

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

  From enrollment to the end of treatment at 16-weeks

Study Arms (1)

In-person Functional Fitness Arm

EXPERIMENTAL

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

Behavioral: Functional Fitness

Interventions

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

In-person Functional Fitness Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Kansas: lead
• University of Kansas Medical Center: collaborator

Study Sites (1)

University of Kansas

Lawrence, Kansas, 66045, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: December 15, 2025
• Study Start: October 17, 2023
• Primary Completion: November 20, 2024
• Study Completion: December 1, 2024
• Last Updated: December 22, 2025

Record last verified: 2025-04

Locations

US (1)