Inflammatory Bowel DiseaseNCT04017637
Resistance Training Intervention to Promote Lean Mass in Youth With IBD
A study testing Resistance Training in people with Inflammatory Bowel Disease, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2020to 6 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
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.
Read the 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.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Resistance Training
- Keywords
- Inflammatory Bowel Disease, Resistance Training, Lean Body Mass, Pediatric
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingBehavioural
Static resistance training including two arm and two leg movements will be performed twice per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body composition as measured by DEXA
Measured: 12 weeks
Change in muscle strength as measured using a hand dynamometer
Measured: 12 weeks
Change in Health-related quality of life as measured by the PedsQL4.0
Measured: 12 weeks
Secondary outcomes (1)
Change in Disease Activity as measured by C-reactive protein blood test
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start6 Mar 2020
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
Why it stopped: Study cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel 2-arm randomized-controlled pilot trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaux J Barnes, PhD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017637
- Sponsor's protocol ID
- BarnesFDGP2019
- Status last verified
- May 2020
- First submitted
- 8 Jul 2019
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Training Intervention to Promote Lean Mass in Youth With IBD
- ClinicalTrials.gov ID
- NCT04017637
- Acronym / sponsor ID
- BarnesFDGP2019
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Inflammatory Bowel Disease, Resistance Training, Lean Body Mass, Pediatric
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study cancelled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel 2-arm randomized-controlled pilot trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Resistance TrainingThose 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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance TrainingStatic resistance training including two arm and two leg movements will be performed twice per week for 12 weeks. | Behavioural | Resistance Training Intervention (RT) |
Primary outcome
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
1 secondary outcome
Change in Disease Activity as measured by C-reactive protein blood test
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training in people with Inflammatory Bowel Disease, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body composition as measured by DEXA (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.