NCT05516030

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2023

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

7 months

First QC Date

July 29, 2022

Last Update Submit

August 22, 2022

Conditions

Outcome Measures

Primary Outcomes (6)

  • Body Mass Index

    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

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

  • Skinfold

    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.

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

  • Strength

    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.

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

  • Flexibility

    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.

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

  • Strength 5-repeition max

    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.

    Change in Week 2 strength at week 12 of the intervention

  • Work Capacity

    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.

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

Secondary Outcomes (10)

  • Perceived Functional Performance

    Change from Baseline perceived functional performance at 13 weeks (post-intervention)

  • Perceived Quality of Life

    Change from Baseline QOL 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)

  • Psychological Need Satisfaction

    Change from Baseline need satisfaction at 13 weeks (post-intervention)

  • +5 more secondary outcomes

Other Outcomes (2)

  • Energy Expenditure

    Week 3 and Week 9 of the intervention

  • Attendance

    Observed each week of the 12-week intervention

Study Arms (1)

HIFT for People with MRD

EXPERIMENTAL

12-week, thrice weekly HIFT intervention for adults with MRD at a local facility that currently hosts HIFT for people with disability and, thus, is conducive to the training needs of individuals with MRD. We will provide financial support for 12-week membership costs, transportation, and participant compensation for completing pre- and post-intervention assessments. Baseline and post-intervention testing will include assessments of weight, body composition, flexibility, and strength, in addition to quality of life, sense of community, self-determination, sleep, and life satisfaction. Each participant will also have energy expenditure assessed during two, randomly selected HIFT sessions during the 12-wk intervention.

Other: HIFT for people with MRD

Interventions

12-wk, 3x/week HIFT participation for individuals with MRD

HIFT for People with MRD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas

Lawrence, Kansas, 66045, United States

RECRUITING

Related Publications (1)

  • Koon LM, Donnelly JE, Washburn R, Sherman JR, Kroeger MM, Swinburne Romine RE, Handlery R, Handlery K. Feasibility and preliminary functional, physical, and psychosocial effects of high-intensity functional training for adults with mobility disabilities. Pilot Feasibility Stud. 2025 Nov 27;11(1):152. doi: 10.1186/s40814-025-01725-2.

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

July 29, 2022

First Posted

August 25, 2022

Study Start

September 1, 2022

Primary Completion

April 4, 2023

Study Completion

April 4, 2023

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations