Clinical trial NCT05516030: HIFT for People With Mobility-Related Disabilities
Official title: Exploring High-intensity Functional Training for People With Mobility-related Disability: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mobility Limitation
Physical Disability
Lead sponsor: University of Kansas
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Investigators will examine the feasibility and health outcomes following a high-intensity functional training intervention for people with mobility-related disabilities. In addition to participant recruitment, attritions rates, and satisfaction, investigators will assess changes to both physical health outcomes (e.g., strength, body composition) and psychosocial outcomes (e.g., quality of life). The findings will provide evidence for the efficacy of HIFT to improve various health outcomes for a population that experiences health disparities in access to, and engagement in, community-based exercise.

Detailed description: The proposed study will examine the feasibility and effectiveness of a high intensity functional training (HIFT) pilot study for adults with mobility-related disabilities (MRD).

Aim 1 will explore the feasibility of a 12-week, thrice weekly HIFT intervention for adults with MRD. Investigators will evaluate participant acceptability and satisfaction, document recruitment challenges, attrition rates, and the adaptive elements of the program for replication and improvement to future clinical trials. Aim 2 will assess the effects of HIFT participation on participant health outcomes, including (i) fitness factors such as work capacity, strength, and energy expenditure; (ii) functional performance; (iii) body composition and weight; and (iv) variables contributing to psychological well-being such as motivation, quality of life, and life satisfaction.

A relatively novel mode of exercise, HIFT stands out for its inclusive approach and adaptable programming, which has the potential to improve health outcomes for a novel target population. The proposed research activities will provide initial data on the feasibility and expected magnitude of change in multiple dimensions of health for people with MRD and contribute to the limited evidence of community-based programs that are adaptable and inclusive. The findings will also allow for the mobilization of this knowledge into disability and healthcare communities to increase the recommendations for exercise for this population and inform future design of clinical trials.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* have a permanent disability that affects mobility (1 year +);
* Never been a part of a functional fitness program before
* no significant health impairment that would contraindicate exercise (physician clearance required)
* serve as their own guardian

Exclusion Criteria:

* younger than 18 years of age
* have a disability that was acquired within 1 year of starting the study or has a non-permanent mobility limitation (e.g., broken arm);
* has previously been involved in functional fitness
* unable to obtain physician clearance
* Are not their own guardian

Primary outcomes:
measure: Body Mass Index
timeFrame: Change from Baseline BMI at 13 weeks (post-intervention)
measure: Skinfold
timeFrame: Change from Baseline 3-site skinfolds at 13 weeks (post-intervention)
measure: Strength
timeFrame: Change from baseline strenghth at 13 weeks (post-intervention)
measure: Flexibility
timeFrame: Change from Baseline flexibility at 13 weeks (post-intervention)
measure: Strength 5-repeition max
timeFrame: Change in Week 2 strength at week 12 of the intervention
measure: Work Capacity
timeFrame: Change in baseline work capacity at weeks 10 and 12 of the intervention
Secondary outcomes:
measure: Perceived Functional Performance
timeFrame: Change from Baseline perceived functional performance at 13 weeks (post-intervention)
measure: Perceived Quality of Life
timeFrame: Change from Baseline QOL at 13 weeks (post-intervention)
measure: Life Satisfaction
timeFrame: Change from Baseline life satisfaction at 13 weeks (post-intervention)
measure: Self-determination
timeFrame: Change from Baseline self-determination at 13 weeks (post-intervention)
measure: Psychological Need Satisfaction
timeFrame: Change from Baseline need satisfaction at 13 weeks (post-intervention)
measure: Sense of Community
timeFrame: Change from Baseline sense of community at 13 weeks (post-intervention)
measure: Shoulder Pain - wheelchair users only
timeFrame: Change from Baseline shoulder pain at 13 weeks (post-intervention)
measure: Exercise Self-efficacy
timeFrame: Change from Baseline self-efficacy at 13 weeks (post-intervention)
measure: Sleep
timeFrame: Change from Baseline sleep at 13 weeks (post-intervention)
measure: Barriers to Health
timeFrame: Change from Baseline perceived barriers at 13 weeks (post-intervention)
Other outcomes:
measure: Energy Expenditure
timeFrame: Week 3 and Week 9 of the intervention
measure: Attendance
timeFrame: Observed each week of the 12-week intervention
Locations:
city: Lawrence
country: United States
facility: University of Kansas
state: Kansas
Study officials:
References: