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A 12-week Exercise Program for Adults With Celiac Disease (MOVE-C)

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: NCT03520244
Recruitment Status : Completed
First Posted : May 9, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
University of Calgary

Brief Summary:
Engagement in regular physical activity (PA) is associated with a range of physical and psychological benefits among chronic disease populations. Celiac disease is a chronic autoimmune condition that requires strict adherence to a gluten-free diet (GFD) for the best medical outcomes, as well as to prevent detrimental health outcomes including bloating, diarrhea, constipation, and increased risk of intestinal cancers and osteoporosis. Despite following a GFD, individuals with celiac disease often report dissatisfaction with the diet, are less likely to engage in social activities, can have an imbalance in gut bacteria and up to 30% still report negative symptoms (e.g., gastro-intestinal upset). Furthermore, preliminary research revealed that rates of PA among those with celiac disease are dismal, with the majority of participants failing to engage in regular PA. The purpose of this pilot research project is to examine the effects of a 12-week structured exercise program on inactive adults with celiac disease. It is anticipated that compared to those in a wait-list control condition, participants who engage in the 12-week exercise program will report greater improvements in quality of life and experience improved balance of gut bacteria. The findings from this project may reveal an additional strategy to optimize health while living with celiac disease. In addition, results from this study will provide essential pilot data that will inform a grant application for a larger clinical trial to further investigate the role of exercise in the promotion of health and well-being among those with celiac disease.

Condition or disease Intervention/treatment Phase
Celiac Disease Behavioral: Exercise + Holistic Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned to one of two groups in parallel for the duration of the study. One group is interventional (exercise + education sessions). This group will be evaluated in parallel against a wait-list control group.
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessors are masked to participant group.
Primary Purpose: Supportive Care
Official Title: Understanding the Relationship Between the MicrobiOme, Vitality and Exercise in Celiac Disease (MOVE-C)
Actual Study Start Date : November 15, 2016
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise + Holistic Education
A 12-week exercise program with 6 bi-weekly education sessions.
Behavioral: Exercise + Holistic Education
The exercise group will undertake a 12-week supervised progressive high intensity interval training program supplemented with 6 bi-weekly group-based holistic education sessions.

No Intervention: Wait list control
Participants in the control group will be offered the exercise + education sessions after the study is complete.



Primary Outcome Measures :
  1. Celiac Disease Quality of Life (CD-QoL) [ Time Frame: Baseline, Immediately Post Program and 3 Months After Program ]
    Assessment of change in Celiac Disease Quality of Life (CD-QoL)

  2. Microbiome [ Time Frame: Baseline, Immediately Post Program and 3 Months After Program ]
    Assessment of change in balance of gut microbiome assessed through stool samples analysis


Secondary Outcome Measures :
  1. Adherence to a Gluten-free Diet [ Time Frame: Baseline, Immediately Post Program and 3 Months After Program ]
    Assessment of change on the Celiac Dietary Adherence Test

  2. Exercise behaviour [ Time Frame: Baseline, Immediately Post Program and 3 Months After Program ]
    Assessment of change in independent exercise behaviour through the Godin Leisure Time Exercise Questionnaire

  3. Self-regulatory efficacy - exercise [ Time Frame: Baseline, Immediately Post Program and 3 Months After Program ]
    Assessment of change in self-regulatory efficacy to exercise

  4. Self-regulatory efficacy - gluten-free diet [ Time Frame: Baseline, Immediately Post Program and 3 Months After Program ]
    Assessment of change in self-regulatory efficacy to eat a strict gluten-free diet

  5. Sleep quality [ Time Frame: Baseline, Immediately Post Program and 3 Months After Program ]
    Assessment of change on the Pittsburg Sleep Quality Index

  6. Gastrointestinal symptoms [ Time Frame: Baseline, Immediately Post Program and 3 Months After Program ]
    Assessment of change on the Gastrointestinal Symptom Rating Scale (CeD-GSRS). This scale consists of 10 items that correspond to intensity, frequency, duration and impact on daily living. Outcomes are rated from 1, no discomfort at all, to 7, very severe discomfort, and are combined to compute a mean score.

  7. Self-compassion - Short form [ Time Frame: Baseline, Immediately Post Program and 3 Months After Program ]
    Assessment of change in self-compassion using the Self-Compassion Scale Short Form (SCS-SF). This scale consists of 12 items with answers ranging from 1 (Almost Never) to 5 (Always). A mean self-compassion score is calculated by taking the reverse score of the negative items prior to calculating the mean.

  8. Waist circumference [ Time Frame: Baseline, Immediately Post Program and 3 Months After Program ]
    Assessment of change in waist circumference in centimeters

  9. Fasting glucose [ Time Frame: Baseline, Immediately Post Program and 3 Months After Program ]
    Assessment of change in fasting blood glucose

  10. Serum lipids [ Time Frame: Baseline, Immediately Post Program and 3 Months After Program ]
    Assessment of change in serum lipids

  11. Blood pressure [ Time Frame: Baseline, Immediately Post Program and 3 Months After Program ]
    Assessment of change in blood pressure following the Canadian Physical Activity Fitness and Lifestyle Appraisal (CPAFLA) protocols.


Other Outcome Measures:
  1. Body composition [ Time Frame: Baseline, Immediately Post Program and 3 Months After Program ]
    Assessment of %body fat and % muscle mass through dual-energy x-ray absorptiometry



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years+, diagnosed with celiac disease (blood test and/or biopsy), lives in the Calgary area, inactive (engage in exercise on 2 or less days of the week for 30 mins or less)

Exclusion Criteria:

  • medical condition preventing engagement in progressive high intensity interval training, unable to attend exercise sessions at the University 2x/week for 12 weeks

Information from the National Library of Medicine

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): NCT03520244


Locations
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Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T3E4E5
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: S. Nicole Culos-Reed, PhD University of Calgary
Principal Investigator: A. Justine Dowd, PhD University of Calgary
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT03520244    
Other Study ID Numbers: REB16-1774
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Calgary:
Microbiome
High intensity interval training
Exercise
Holistic education
Quality of life
Fatigue
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases