A 12-week Exercise Program for Adults With Celiac Disease (MOVE-C)
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ClinicalTrials.gov Identifier: NCT03520244 |
Recruitment Status :
Completed
First Posted : May 9, 2018
Last Update Posted : September 28, 2018
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Condition or disease | Intervention/treatment | Phase |
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Celiac Disease | Behavioral: Exercise + Holistic Education | Not Applicable |

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 |

Arm | Intervention/treatment |
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Experimental: Exercise + Holistic Education
A 12-week exercise program with 6 bi-weekly education sessions.
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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.
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- 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)
- 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
- 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
- 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
- Self-regulatory efficacy - exercise [ Time Frame: Baseline, Immediately Post Program and 3 Months After Program ]Assessment of change in self-regulatory efficacy to exercise
- 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
- Sleep quality [ Time Frame: Baseline, Immediately Post Program and 3 Months After Program ]Assessment of change on the Pittsburg Sleep Quality Index
- 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.
- 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.
- Waist circumference [ Time Frame: Baseline, Immediately Post Program and 3 Months After Program ]Assessment of change in waist circumference in centimeters
- Fasting glucose [ Time Frame: Baseline, Immediately Post Program and 3 Months After Program ]Assessment of change in fasting blood glucose
- Serum lipids [ Time Frame: Baseline, Immediately Post Program and 3 Months After Program ]Assessment of change in serum lipids
- 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.
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Canada, Alberta | |
University of Calgary | |
Calgary, Alberta, Canada, T3E4E5 |
Principal Investigator: | S. Nicole Culos-Reed, PhD | University of Calgary | |
Principal Investigator: | A. Justine Dowd, PhD | University of Calgary |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Microbiome High intensity interval training Exercise |
Holistic education Quality of life Fatigue |
Celiac Disease Malabsorption Syndromes Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases |