NCT03520244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 9, 2018

Completed
Last Updated

September 28, 2018

Status Verified

April 1, 2018

Enrollment Period

1.4 years

First QC Date

February 21, 2017

Last Update Submit

September 26, 2018

Conditions

Celiac Disease

Keywords

MicrobiomeHigh intensity interval trainingExerciseHolistic educationQuality of lifeFatigue

Outcome Measures

Primary Outcomes (2)

  • Celiac Disease Quality of Life (CD-QoL)

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

    Baseline, Immediately Post Program and 3 Months After Program

  • Microbiome

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

    Baseline, Immediately Post Program and 3 Months After Program

Secondary Outcomes (11)

  • Adherence to a Gluten-free Diet

    Baseline, Immediately Post Program and 3 Months After Program

  • Exercise behaviour

    Baseline, Immediately Post Program and 3 Months After Program

  • Self-regulatory efficacy - exercise

    Baseline, Immediately Post Program and 3 Months After Program

  • Self-regulatory efficacy - gluten-free diet

    Baseline, Immediately Post Program and 3 Months After Program

  • Sleep quality

    Baseline, Immediately Post Program and 3 Months After Program

  • +6 more secondary outcomes

Other Outcomes (1)

  • Body composition

    Baseline, Immediately Post Program and 3 Months After Program

Study Arms (2)

Exercise + Holistic Education

EXPERIMENTAL

A 12-week exercise program with 6 bi-weekly education sessions.

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.

Interventions

Exercise + Holistic EducationBEHAVIORAL

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.

Exercise + Holistic Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T3E4E5, Canada

Location

Related Publications (2)

  • 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.

    PMID: 34038293DERIVED

  • 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.

    PMID: 32961065DERIVED

MeSH Terms

Conditions

Celiac DiseaseMotor ActivityFatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • S. Nicole Culos-Reed, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

  • A. Justine Dowd, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessors are masked to participant group.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2017

First Posted

May 9, 2018

Study Start

November 15, 2016

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

September 28, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)