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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| Exercise + Holistic Education | Experimental | A 12-week exercise program with 6 bi-weekly education sessions. Receives: Behavioral: Exercise + Holistic Education |
| Wait list control | No intervention | Participants 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.
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
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)
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
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
Self-regulatory efficacy - exercise
Assessment of change in self-regulatory efficacy to exercise
Measured: Baseline, Immediately Post Program and 3 Months After Program
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
Sleep quality
Assessment of change on the Pittsburg Sleep Quality Index
Measured: Baseline, Immediately Post Program and 3 Months After Program
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
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
Waist circumference
Assessment of change in waist circumference in centimeters
Measured: Baseline, Immediately Post Program and 3 Months After Program
Fasting glucose
Assessment of change in fasting blood glucose
Measured: Baseline, Immediately Post Program and 3 Months After Program
Serum lipids
Assessment of change in serum lipids
Measured: Baseline, Immediately Post Program and 3 Months After Program
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.
- First posted9 May 2018
- Study start15 Nov 2016
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- S. Nicole Culos-Reed, PhD, Principal investigator, University of CalgaryA. Justine Dowd, PhD, Principal investigator, University of Calgary
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 34038293Warbeck 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Relationship Between the MicrobiOme, Vitality and Exercise in Celiac Disease (MOVE-C)
- ClinicalTrials.gov ID
- NCT03520244
- Acronym / sponsor ID
- MOVE-C / REB16-1774
- Conditions
- Celiac Disease
- Keywords
- Microbiome, High intensity interval training, Exercise, Holistic education, Quality of life, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 9 May 2018 (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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise + Holistic Education | Experimental | Behavioral: Exercise + Holistic EducationA 12-week exercise program with 6 bi-weekly education sessions. |
| Wait list control | No intervention | –Participants in the control group will be offered the exercise + education sessions after the study is complete. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- medical condition preventing engagement in progressive high intensity interval training, unable to attend exercise sessions at the University 2x/week for 12 weeks
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 |
|---|---|---|
| Exercise + Holistic EducationThe exercise group will undertake a 12-week supervised progressive high intensity interval training program supplemented with 6 bi-weekly group-based holistic education sessions. | Behavioural | Exercise + Holistic Education |
Primary outcome
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
11 secondary outcomes
Adherence to a Gluten-free Diet
Time frame: Baseline, Immediately Post Program and 3 Months After Program
Exercise behaviour
Time frame: Baseline, Immediately Post Program and 3 Months After Program
Self-regulatory efficacy - exercise
Time frame: Baseline, Immediately Post Program and 3 Months After Program
Self-regulatory efficacy - gluten-free diet
Time frame: Baseline, Immediately Post Program and 3 Months After Program
Sleep quality
Time frame: Baseline, Immediately Post Program and 3 Months After Program
Gastrointestinal symptoms
Time frame: Baseline, Immediately Post Program and 3 Months After Program
Self-compassion - Short form
Time frame: Baseline, Immediately Post Program and 3 Months After Program
Waist circumference
Time frame: Baseline, Immediately Post Program and 3 Months After Program
Fasting glucose
Time frame: Baseline, Immediately Post Program and 3 Months After Program
Serum lipids
Time frame: Baseline, Immediately Post Program and 3 Months After Program
Blood pressure
Time frame: Baseline, Immediately Post Program and 3 Months After Program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Derived from this study: PubMed 34038293Dowd 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.
- Derived from this study: PubMed 32961065Warbeck 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.
- 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.
S. Nicole Culos-Reed, PhD principal investigator
University of Calgary
A. Justine Dowd, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
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.