Resistance Training Intervention to Promote Lean Mass in Youth With IBD

NCT04017637 | Withdrawn

• 1 other identifier: BarnesFDGP2019
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate feasibility, safety, and preliminary estimates of resistance training (RT) efficacy to promote lean body mass accrual in patients with CD aged 14-18. This will be achieved by conducting a parallel 2-arm randomized-controlled pilot trial of RT compared to usual care. At weeks 0 (pre-treatment), 6 (mid-treatment), and 12 (post- treatment), feedback regarding safety, feasibility, and acceptability will be collected from participants through surveys and interviews. Magnitude of the effect size of the intervention on LBM, muscle strength, and health-related quality of life (HRQoL) will also be estimated.

Conditions

Inflammatory Bowel Disease

Keywords

Inflammatory Bowel Disease; Resistance Training; Lean Body Mass; Pediatric

Outcome Measures

Primary Outcomes (3)

• Change in body composition as measured by DEXA

  12 weeks

• Change in muscle strength as measured using a hand dynamometer

  12 weeks

• Change in Health-related quality of life as measured by the PedsQL4.0

  12 weeks

Secondary Outcomes (1)

• Change in Disease Activity as measured by C-reactive protein blood test

  12 weeks

Other Outcomes (1)

• Total number of intervention sessions attended

  12 weeks

Study Arms (2)

Usual Care (UC)

NO INTERVENTION

Those randomized to the UC group will complete baseline and post-intervention assessments only. No intervention will be administered.

Resistance Training Intervention (RT)

EXPERIMENTAL

Those randomized to the RT group will complete baseline and post-intervention assessments at weeks 0 and 12. For the intervention, they will complete resistance training for approximately 12 minutes 2x per week for 12 weeks.

Behavioral: Resistance Training

Interventions

Resistance Training BEHAVIORAL

Static resistance training including two arm and two leg movements will be performed twice per week for 12 weeks.

Resistance Training Intervention (RT)

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• aged 14-18
• diagnosed with Crohn's Disease
• able to read, write, and speak English
• have a consenting caregiver who can commit to all study procedures
• have clearance from their primary treating IBD physician to enroll in the RT intervention

You may not qualify if:

• history of neuro-developmental or neuro-motor disorder (including but not limited to Intellectual Disability, Down Syndrome, or Cerebral Palsy)
• presence of another medical condition that prevents them from being able to participate in physical activity
• currently participating in a formal exercise or physical activity program beyond physical education offered at school
• currently on systemic steroids

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

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

Model Details: Parallel 2-arm randomized-controlled pilot trial

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 12, 2019
• Study Start: March 6, 2020
• Primary Completion: March 6, 2020
• Study Completion: March 6, 2020
• Last Updated: June 2, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)