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Resistance Training Intervention to Promote Lean Mass in Youth With IBD

Primary Purpose

Inflammatory Bowel Disease

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance Training
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inflammatory Bowel Disease focused on measuring Inflammatory Bowel Disease, Resistance Training, Lean Body Mass, Pediatric

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria.

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care (UC)

Resistance Training Intervention (RT)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in body composition as measured by DEXA
Change in muscle strength as measured using a hand dynamometer
Change in Health-related quality of life as measured by the PedsQL4.0

Secondary Outcome Measures

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

Full Information

First Posted
July 8, 2019
Last Updated
May 29, 2020
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04017637
Brief Title
Resistance Training Intervention to Promote Lean Mass in Youth With IBD
Official Title
Resistance Training Intervention to Promote Lean Mass in Youth With IBD
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Study cancelled
Study Start Date
March 6, 2020 (Actual)
Primary Completion Date
March 6, 2020 (Actual)
Study Completion Date
March 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Lean body mass (LBM) deficits are common in Crohn's Disease (CD) and persist beyond achievement of remission. In a recent review of 21 studies with a total of 1,479 youth with Inflammatory Bowel Disease (IBD), 93.6% of patients with CD showed deficits in LBM compared to healthy controls. LBM deficits in CD are multifactorial though largely explained by malnutrition. Even with weight restoration and remission however, youth with CD continue to show deficits in LBM compared to healthy peers. Despite proportional deficits in fat and LBM at baseline, weight restoration is explained by gains in fat without similar gains in LBM, suggesting that additional mechanisms interact to maintain deficits such as low physical activity (PA) or altered energy partitioning. Chronic LBM deficits can have deleterious effects including decreased physical function, myopenia, metabolic dysregulation, increased risk of infection, compromised peak bone mass accrual, and development of osteopenia/osteoporosis. While some factors are not readily modifiable (e.g. underlying disease mechanisms), targeting factors amenable to change may result in an increase in LBM and thus improved health outcomes. Health behaviors, including exercise, are modifiable and associated with the development of LBM. Resistance training (RT) has been associated with improved LBM in youth with and without chronic illness. To our knowledge, no evidence-based resistance training interventions have been developed to promote LBM accrual in pediatric CD. The overarching aims of this proposal are to evaluate the safety, feasibility, and effects of 12 weeks of RT on LBM in youth with CD aged 14-18. Specifically we aim to: Aim 1: Evaluate feasibility, safety, and preliminary estimates of RT efficacy to promote LBM 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. Positive findings would have broad implications for growth and long-term health outcomes including bone disease and metabolic health in these young patients. More broadly, the findings would have promising potential to be extended to patients with IBD across the developmental and disease spectrum including youth with ulcerative colitis (UC) and adults with IBD as they demonstrate similar LBM deficits. The proposed study will also provide preliminary data to inform a evaluation through a larger trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
Keywords
Inflammatory Bowel Disease, Resistance Training, Lean Body Mass, Pediatric

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel 2-arm randomized-controlled pilot trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care (UC)
Arm Type
No Intervention
Arm Description
Those randomized to the UC group will complete baseline and post-intervention assessments only. No intervention will be administered.
Arm Title
Resistance Training Intervention (RT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Resistance Training
Intervention Description
Static resistance training including two arm and two leg movements will be performed twice per week for 12 weeks.
Primary Outcome Measure Information:
Title
Change in body composition as measured by DEXA
Time Frame
12 weeks
Title
Change in muscle strength as measured using a hand dynamometer
Time Frame
12 weeks
Title
Change in Health-related quality of life as measured by the PedsQL4.0
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Disease Activity as measured by C-reactive protein blood test
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Total number of intervention sessions attended
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria. 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 Exclusion Criteria: 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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Resistance Training Intervention to Promote Lean Mass in Youth With IBD

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