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Recruitment Status : Withdrawn (Study cancelled)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
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Disease||Behavioral: Resistance Training||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel 2-arm randomized-controlled pilot trial|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Resistance Training Intervention to Promote Lean Mass in Youth With IBD|
|Actual Study Start Date :||March 6, 2020|
|Actual Primary Completion Date :||March 6, 2020|
|Actual Study Completion Date :||March 6, 2020|
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.
Behavioral: Resistance Training
Static resistance training including two arm and two leg movements will be performed twice per week for 12 weeks.
- 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 ]
- Change in Disease Activity as measured by C-reactive protein blood test [ Time Frame: 12 weeks ]
- Total number of intervention sessions attended [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017637
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35233|