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Clinical Trials/NCT05516030
NCT05516030
Unknown
Not Applicable

Exploring High-intensity Functional Training for People With Mobility-related Disability: A Pilot Study

University of Kansas1 site in 1 country12 target enrollmentSeptember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mobility Limitation
Sponsor
University of Kansas
Enrollment
12
Locations
1
Primary Endpoint
Flexibility
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
April 4, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lyndsie Koon

Assistant Research Professor

University of Kansas

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

Outcomes

Primary Outcomes

Flexibility

Time Frame: Change from Baseline flexibility at 13 weeks (post-intervention)

Back Scratch Test (Jones \& Rikli, 2002) - 1 arm above the head, bent elbow, reach down across the back as far as possible. Simultaneously, the opposite arm bent at elbow and forearm is extended up along the back as far as possible to that the fingers of both hands meet or overlap. The distance of overlap or the distance between the tips of the middle fingers is measured in centimeters.

Body Mass Index

Time Frame: Change from Baseline BMI at 13 weeks (post-intervention)

Weight will be measured in duplicate using a portable calibrated, digital scale to the nearest 0.1 kg. Height will be measured in meters, and body mass index (BMI) will be calculated with the following formula: kg/m2

Strength 5-repeition max

Time Frame: Change in Week 2 strength at week 12 of the intervention

Participants will complete 5-repetition max strength testing at week 2 of the intervention, and again at week 12. This will include a 5-RM assessment of the deadlift, press (standing or seated) and squat. Outcome variables will be reported to the nearest kg with regard to weight successfully moved for 5 repetitions.

Work Capacity

Time Frame: Change in baseline work capacity at weeks 10 and 12 of the intervention

Participants will complete 2 work capacity tests during week 3 (A1) and 5 (A2), and again at weeks 10 (A1) and 12 (A2). A1 will be assessed by the outcome measure of time to complete the benchmark exercise session - in minutes and seconds; and A2 will be assessed by number of rounds and repetitions completed during the exercise session in a given amount of time.

Strength

Time Frame: Change from baseline strenghth at 13 weeks (post-intervention)

Grip Strength with dynameter. Participants will be seated with elbow flexed at 90 degrees, forearm in a neutral position and write between 0 and 30 degrees of flexion. participants will use their dominant hand and the 5 second squeeze will occur in duplicate, with 15 second rest in between and the score averaged to the nearest 0.1 kg.

Skinfold

Time Frame: Change from Baseline 3-site skinfolds at 13 weeks (post-intervention)

3-site skinfold test as outlined by Jackson \& Polloc (1978; 1980) on 3 site measures (men: chest, abdomen, thigh; women: triceps, suprailium, thigh). The same investigator will measure all 3 sites using a Harpenden Skinfold Caliper in triplicate, and the true skinfold thickness was taken as an average of teh three measures.

Secondary Outcomes

  • Barriers to Health(Change from Baseline perceived barriers at 13 weeks (post-intervention))
  • Exercise Self-efficacy(Change from Baseline self-efficacy at 13 weeks (post-intervention))
  • Life Satisfaction(Change from Baseline life satisfaction at 13 weeks (post-intervention))
  • Self-determination(Change from Baseline self-determination at 13 weeks (post-intervention))
  • Perceived Functional Performance(Change from Baseline perceived functional performance at 13 weeks (post-intervention))
  • Psychological Need Satisfaction(Change from Baseline need satisfaction at 13 weeks (post-intervention))
  • Perceived Quality of Life(Change from Baseline QOL at 13 weeks (post-intervention))
  • Sense of Community(Change from Baseline sense of community at 13 weeks (post-intervention))
  • Shoulder Pain - wheelchair users only(Change from Baseline shoulder pain at 13 weeks (post-intervention))
  • Sleep(Change from Baseline sleep at 13 weeks (post-intervention))

Study Sites (1)

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