Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Resistance Training Intervention to Promote Lean Mass in Youth With IBD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04017637
Recruitment Status : Withdrawn (Study cancelled)
First Posted : July 12, 2019
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Margaux J Barnes, PhD, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE July 12, 2019
Last Update Posted Date June 2, 2020
Actual Study Start Date  ICMJE March 6, 2020
Actual Primary Completion Date March 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2019)
  • Change in body composition as measured by DEXA [ Time Frame: 12 weeks ]
  • Change in muscle strength as measured using a hand dynamometer [ Time Frame: 12 weeks ]
  • Change in Health-related quality of life as measured by the PedsQL4.0 [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2019)
Change in Disease Activity as measured by C-reactive protein blood test [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 10, 2019)
Total number of intervention sessions attended [ Time Frame: 12 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Resistance Training Intervention to Promote Lean Mass in Youth With IBD
Official Title  ICMJE Resistance Training Intervention to Promote Lean Mass in Youth With IBD
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel 2-arm randomized-controlled pilot trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Inflammatory Bowel Disease
Intervention  ICMJE Behavioral: Resistance Training
Static resistance training including two arm and two leg movements will be performed twice per week for 12 weeks.
Study Arms  ICMJE
  • No Intervention: Usual Care (UC)
    Those randomized to the UC group will complete baseline and post-intervention assessments only. No intervention will be administered.
  • Experimental: Resistance Training Intervention (RT)
    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: Behavioral: Resistance Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 29, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2019)
30
Actual Study Completion Date  ICMJE March 6, 2020
Actual Primary Completion Date March 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04017637
Other Study ID Numbers  ICMJE BarnesFDGP2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Margaux J Barnes, PhD, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Alabama at Birmingham
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP