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Celiac DiseaseMOVE-CNCT03520244

A 12-week Exercise Program for Adults With Celiac Disease

A study testing Exercise + Holistic Education in people with Celiac Disease, run by University of Calgary at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Celiac Disease
What is being tested?
Exercise + Holistic Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteCanada
Study dates
15 Nov 2016to 30 Mar 2018
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Calgary

    Calgary, Alberta, T3E4E5

Other trials in Canada

About this study

Official title: Understanding the Relationship Between the MicrobiOme, Vitality and Exercise in Celiac Disease (MOVE-C)

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.

Read the detailed description

Background \& Rationale:

Engagement in regular physical activity (PA) is associated with a range of physical and psychological benefits among chronic disease populations. Quality of life (QoL) is significantly higher among people with cancer, depression and coronary heart disease who engage in PA on a regular basis. Risk of other chronic diseases such as type 2 diabetes is significantly reduced when people engage in regular PA. In addition, findings from a recent intervention study revealed that after engaging in a 12-week structured exercise program, cancer survivors had improvements in physical functioning, and reductions in fatigue and tiredness.

One chronic disease population that could particularly benefit from engaging in regular PA is people with celiac disease. Celiac disease is a chronic autoimmune condition and the incidence has increased 4 to 5 times over the past 50 years. Strict adherence to a gluten-free diet (GFD) is currently the only treatment for preventing both short- and long-term consequences from celiac disease (e.g., infertility, intestinal cancers, osteoporosis). Unfortunately, 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. Further, following a strict GFD alone may not be sufficient to effectively manage the disease, and can be associated with detrimental outcomes including reduced QoL. Despite following a GFD, individuals with celiac disease report high treatment burden, lower social engagement, fatigue, altered gut microbiota, and up to 30% still report negative symptoms (e.g., gastro-intestinal upset). Given the benefits of engagement in regular PA for other chronic disease populations, helping people with celiac disease become more physically active may lead to improvements in QoL and physiological outcomes.

High-Intensity Interval Training (HIIT) has been found to be appropriate for those with lifestyle-induced chronic diseases, including type 2 diabetes, atherosclerotic cardiovascular disease and metabolic syndrome. HIIT involves repeated bouts of high intensity effort followed by varied recovery times and can be easily modified for people of all fitness levels and chronic conditions. For example, Jung and colleagues reported on the benefits of HIIT for people with pre-diabetes and found that compared to participants engaging in moderate intensity continuous training, participants who engaged in regular bouts of HIIT exercise had better adherence to independent exercise. Martinez et al. found that participants who engaged in shorter interval training (e.g., HIIT), reported more pleasure and enjoyment of the exercise when compared to heavy, continuous or longer interval exercise. In addition to improvements in behavioural outcomes, Denou and colleagues recently found that HIIT also led to improvements in the gut microbiota of mice with diet induced obesity. Given that people with celiac disease are at increased risk of metabolic syndrome and are likely to have gut dysbiosis (imbalance in gut microorganisms), it is anticipated that HIIT may lead to improvements in key psychosocial (e.g., QoL) and behavioural outcomes (i.e., exercise adherence). Further, key markers of metabolic syndrome and balance in the gut microbiota may be positively impacted.

Study aims:

The proposed study is an innovative examination of the effects of exercise on physiological and patient-reported outcomes among people with celiac disease. Specifically, we will explore the effects of a 12-week HIIT and lifestyle intervention on QoL, gut microbiota profile, independent PA, fatigue, and markers of metabolic syndrome (waist circumference, fasting glucose, serum lipids, blood pressure) among people with celiac disease who are currently sedentary (i.e., not meeting Canada's PA Recommendations (150 minutes of weekly activity at a moderate intensity or greater).

Exercise program:

The 12-week exercise program will entail two 60-minute structured group exercise sessions per week. As participants will not be meeting the recommended guidelines for weekly PA, workouts will be progressive in nature and an initial conditioning phase will be integrated into the 12-week program. Participants will begin with 20-30 minute exercise sessions and progress to 40-60 minute sessions over the course of 12 weeks. Each class will consist of warm-up, training period, cool-down and flexibility sections. Participants will have the option of using various pieces of equipment, including stationary bikes, treadmills and ellipticals. All participants will wear heart rate monitors in order to monitor workout intensity. Participants' programs will be designed by a Canadian Society of Exercise Physiology (CSEP) Certified Exercise Physiologist® and exercise classes will be supervised by a CSEP-Certified Personal Trainer®.

Education sessions:

Participants in the exercise condition will participate in 30-minute bi-weekly group education sessions. Education will pertain to learning about the importance of following a nutritious, whole foods-based GFD to effectively manage celiac disease, communication strategies, effective sleep hygiene practices, and strategies to overcome barriers to following a strict GFD. Participants will also be taught behaviour change skills based on the theoretically-based group-mediated cognitive behavioural (GMCB) approach. GMCB interventions teach participants how to self-monitor daily activity, set goals and overcome barriers to regular PA. To prevent dependence on the group, self-regulation becomes a greater emphasis over the course of the GMCB sessions. Previous GMCB interventions have lead to greater improvements in frequency of PA, long-term adherence, fitness, self-efficacy for mobility, and barrier self-efficacy.

Conditions
Celiac Disease
Being tested
Exercise + Holistic Education
Keywords
Microbiome, High intensity interval training, Exercise, Holistic education, Quality of life, Fatigue
Medical subject headings
Celiac Disease, Motor Activity, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise + Holistic EducationBehavioural

    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.

Study groups in NCT03520244
Study groupRoleWhat they receive
Exercise + Holistic EducationExperimentalA 12-week exercise program with 6 bi-weekly education sessions.
Receives: Behavioral: Exercise + Holistic Education
Wait list controlNo interventionParticipants in the control group will be offered the exercise + education sessions after the study is complete.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Celiac Disease Quality of Life (CD-QoL)

    Assessment of change in Celiac Disease Quality of Life (CD-QoL)

    Measured: Baseline, Immediately Post Program and 3 Months After Program

  2. Microbiome

    Assessment of change in balance of gut microbiome assessed through stool samples analysis

    Measured: Baseline, Immediately Post Program and 3 Months After Program

Secondary outcomes (11)
  1. Adherence to a Gluten-free Diet

    Assessment of change on the Celiac Dietary Adherence Test

    Measured: Baseline, Immediately Post Program and 3 Months After Program

  2. Exercise behaviour

    Assessment of change in independent exercise behaviour through the Godin Leisure Time Exercise Questionnaire

    Measured: Baseline, Immediately Post Program and 3 Months After Program

  3. Self-regulatory efficacy - exercise

    Assessment of change in self-regulatory efficacy to exercise

    Measured: Baseline, Immediately Post Program and 3 Months After Program

  4. Self-regulatory efficacy - gluten-free diet

    Assessment of change in self-regulatory efficacy to eat a strict gluten-free diet

    Measured: Baseline, Immediately Post Program and 3 Months After Program

  5. Sleep quality

    Assessment of change on the Pittsburg Sleep Quality Index

    Measured: Baseline, Immediately Post Program and 3 Months After Program

  6. Gastrointestinal symptoms

    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.

    Measured: Baseline, Immediately Post Program and 3 Months After Program

  7. Self-compassion - Short form

    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.

    Measured: Baseline, Immediately Post Program and 3 Months After Program

  8. Waist circumference

    Assessment of change in waist circumference in centimeters

    Measured: Baseline, Immediately Post Program and 3 Months After Program

  9. Fasting glucose

    Assessment of change in fasting blood glucose

    Measured: Baseline, Immediately Post Program and 3 Months After Program

  10. Serum lipids

    Assessment of change in serum lipids

    Measured: Baseline, Immediately Post Program and 3 Months After Program

  11. Blood pressure

    Assessment of change in blood pressure following the Canadian Physical Activity Fitness and Lifestyle Appraisal (CPAFLA) protocols.

    Measured: Baseline, Immediately Post Program and 3 Months After Program

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2018
  2. Study start15 Nov 2016
  3. Primary completion30 Mar 2018
  4. Study completion30 Mar 2018

Resources

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
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 blind
Who is masked
Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03520244
Sponsor's protocol ID
REB16-1774
Acronym
MOVE-C
Status last verified
Apr 2018
First submitted
21 Feb 2017
Last updated
28 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dowd AJ, Kronlund L, Warbeck C, Parmar C, Daun JT, Wytsma-Fisher K, Reimer RA, Millet G, Fung T, Culos-Reed SN. Effects of a 12-week HIIT + group mediated cognitive behavioural intervention on quality of life among inactive adults with coeliac disease: findings from the pilot MOVE-C study. Psychol Health. 2022 Apr;37(4):440-456. doi: 10.1080/08870446.2021.1921774. Epub 2021 May 26.

    PubMed 34038293
  • Warbeck C, Dowd AJ, Kronlund L, Parmar C, Daun JT, Wytsma-Fisher K, Millet GY, Schick A, Reimer RA, Fung T, Culos-Reed SN. Feasibility and effects on the gut microbiota of a 12-week high-intensity interval training plus lifestyle education intervention on inactive adults with celiac disease. Appl Physiol Nutr Metab. 2021 Apr;46(4):325-336. doi: 10.1139/apnm-2020-0459. Epub 2020 Sep 22.

    PubMed 32961065

Questions about this trial

What is this clinical trial studying?

A study testing Exercise + Holistic Education in people with Celiac Disease, run by University of Calgary at 1 site in Canada.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 Sep 2018. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Celiac Disease Quality of Life (CD-QoL) (time frame: Baseline, Immediately Post Program and 3 Months After Program). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03520244, which also lists 2 linked publications.

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 28 Sep 2018.

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