Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04302623 |
| Other study ID # |
REB20-0084 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
January 14, 2022 |
Study information
| Verified date |
April 2022 |
| Source |
University of Calgary |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Study Aim: This study will explore the feasibility and effectiveness of a yoga program for
patients with IBS.
Methods: A superiority RCT with 30 participants per group. Adult patients with IBS fluent in
English who do not have major physical impairments or cognitive, psychological, or
psychiatric disorder will be recruited and randomly using the REDCap randomization module to
either a yoga intervention delivered (a) a yoga intervention delivered online led by a yoga
facilitator or (b) a advice only control group. The 8-week Hatha Yoga intervention consists
of Yoga Namaskar, Nadi Shuddhi (alternate nostril breathing), mantra chanting, and breath
watching.
Group 1: Yoga program. Participants will be asked to practice the yoga program daily at home
and will be given access to the yoga videos hosted on the University of Calgary study
website, as well as written program instructions, and frequently answered questions. A brief
description of the video content will be provided to inform the participant of its content
and length. Additional website content will include study information, study schedule, and
contact information, as well as a pre-recorded educational session. In addition to the daily
program describe above, the facilitator-led intervention will be delivered online by a
certified yoga facilitator using the Microsoft Teams platform. Participants in group of 3 to
5 will be collated to enhance effectiveness of the study processes. Our team has experience
with this approach, as this strategy is currently used with previous yoga study. Yoga classes
will be held once per week for 8 weeks, with the first session lasting approximately 1.5
hours and subsequent sessions up to 60 minutes. The total allocated time for the introductory
session will include the class set-up, introductions, educational material (please see
below), overview of practices, teaching of practices, practice corrections/enhancements,
modifications, and practice expectations. Each follow-up class will include review from the
previous week, questions and answers, individual corrections and/or modifications. For
individual corrections, the yoga facilitator will ask the participant to do the practices and
receive corrections, if needed.
Group 2. Advice-only control group. This group will receive general education on IBS, the
mind and gut connection, and the role of mind-body therapies in the management of IBS.
Effectiveness outcomes will be assessed at baseline and 8 weeks. The primary effectiveness
outcome will be the severity of IBS symptoms, and secondary effectiveness outcomes include
microbiome analysis, quality of life, anxiety and depression symptoms, perceived stress,
fatigue, and severity of somatic symptoms. Microbiome composition will be measured using
shotgun metagenomic sequencing. Microbiome sequences will be analyzed for alpha diversity,
beta diversity, species composition, functional composition and biomarker discovery. To
determine the feasibility of each intervention, recruitment and attrition rates, adherence,
program preferences and satisfaction, and adverse event outcomes will be evaluated.
Description:
Study Aim. This study will explore the feasibility and effectiveness of a yoga program for
patients with IBS. Objective. Examine the feasibility and effectiveness of an 8-week online
live facilitator-led yoga program compared to a wait-list control. Hypothesis. Yoga delivered
online live by a facilitator will have the superior effectiveness in reducing IBS symptoms
compared to advice only control group after 8 weeks.
Background
IBS is a highly prevalent disorder affecting 12% of Canadians. One in five individuals with
IBS has one or more psychiatric disorder, and 50% have at least one comorbid somatic symptom.
Frequently used therapies are targeted toward symptom reduction with modest benefits, whereas
treatments with greater therapeutic effect may be associated with side effects. This leaves
many patients dissatisfied with their symptom management, resulting in half of patients using
alternative therapies. The underlying cause of IBS is likely multifactorial and the interplay
of the brain-gut axis in the pathophysiology of IBS has been well established. An altered
stress response, arising through either psychological and/or physiological mechanisms is
hypothesized to be involved in the impairment of the signalling between the brain and the
gut. This demonstrates a connection between gut function, stress, and psychological
processes. Therefore, therapies that focus on mind-body interactions and stress reduction,
may be useful adjunctive treatments for IBS.
Yoga is a traditional "mind-body-breath" discipline that includes yogic postures, structured
breathing, and meditation. Several potential mechanisms for the effectiveness of yoga that
have applicability to IBS have been proposed, including reducing the upregulated sympathetic
activity and increasing the parasympathetic response. The investigator's recent review of the
literature has identified four randomized controlled trials that examined traditional yoga
practice as therapy for adult IBS patients. All trials found yoga as more effective compared
to pharmacological treatment, and equally effective as dietary interventions or
moderate-intensity walking. Both physical (IBS symptom severity, gastric motility, autonomic
and somatic symptom scores, physical functioning) and mental (depression, anxiety,
GI-specific anxiety, and QOL) improvements were seen. The current literature supports that
yoga is effective, safe and it may target multiple mechanisms involved in the treatment of
IBS symptoms as previously described. Although yoga is effective in managing IBS symptoms,
further research is needed to determine the feasibility and effectiveness of yoga as a
therapeutic option in clinical practice for patients with IBS, while also examining delivery
strategies (face-to-face vs. online) to more optimally understand how to sequence therapeutic
interventions and whether this improves initiation and adherence to the intervention.
Research Methods
Study Design. Superiority trial.
Recruitment. Potential participants will be identified through several avenues, including:
1. Gastroenterologists will screen IBS patients using the study eligibility criteria and
following the patient's verbal consent, will share the patient's contact information
with the study coordinator. Patients have previously given verbal permission at the
clinic to their gastroenterologist to be asked to participate in research studies.
2. Self-referral through poster advertising in the GI clinics at Foothills and South Health
Campus. In addition, the study will be advertised on the Faculty of Medicine TVs on the
Foothills campus.
3. IMAGINE (Inflammation, Microbiome and Alimentation Gastro-intestinal and
Neuropsychiatric Effects) cohort study at the University of Calgary: The IMAGINE study
will send an initial email to all its IBS patients who have consented to be contacted
for future studies. This email will explain the current study and connect interested
participants with the study coordinator.
4. Self-referral through the Primary Care Networks (PCNs) in Calgary. Primary care
physicians and/or dieticians (depending on the PCN clinic) will inform their IBS
patients of the study and provide the patient with a brochure.
5. Through the use of a privately owned Facebook group called 'Low FODMAP Canadians', a
group managed by two Canadian dieticians Lauren Renlund, MPH, RD and Audrey Inouye, RD.
This group has over 2.1K members who have IBS.
6. Participants who indicated interest in this study in a previous survey (REB19-1456) and
have given their consent to be contacted.
Screening. Consented participants will complete a mental health evaluation using the Patient
Health Questionnaire-9 (PHQ-9). Individuals who score 20 points or higher on the PHQ-9
indicating sever depression will not be eligible to participate.
Intervention. Participants will be assigned randomly using the REDCap randomization module to
either (a) a yoga intervention delivered online led by a yoga facilitator or (b) a advice
only control group. The intervention group will receive a yoga program described below called
Upa Yoga, including yoga Namaskar, Nadi Shuddi (alternate nostril breathing), mantra
meditation, and breath watching. The intervention was developed in keeping with the ancient
principles of Hatha Yoga and delivered by a trained yoga facilitator from the Isha Yoga
Institute of Inner Sciences.
- Yoga Namaskar activates the lumbar region of the spine and strengthens the core muscles.
This set of practices involves a series of 7 steps including stretching, squatting and
structured breathing sequences which will take 10 minutes to complete.
- Nadi Shuddhi or alternate nostril breathing helps to bring balance between activity and
emotion. Participants will sit in a cross-legged posture with the spine comfortably
erect, eyes closed with the left hand laced in the middle of the lap, palm facing
upwards, and the ring and index finger will be used to block one nostril while inhaling
and exhaling through the other. This practice takes a minimum of 5 minutes to complete.
- Mantra Meditation. In the yogic culture, the entire existence is seen as a web of sounds
or vibrations, for which the root sounds are "Aa, Oo, and Mm". These three sounds are
referred to as universal sounds. This mantra, Aum, facilitates energy flow, and through
vibratory mechanisms, has been demonstrated to create peace and harmony. This will be
practiced for 3 minutes.
- Breath Watching. The science of breath watching in the yogic literature, employs the
following principle: a certain thought, emotion or change in the physical body might
change the breath flow. Similarly, the converse of principle is true, in that breathing
in a structured manner can be used as a tool to bring positive changes to the
practioners' mind, body and emotions. The practioners will assume a specific
cross-legged physical posture, and practice breath watching as guided by the yoga
instructor for 3-5-minutes.
Group 1: Yoga program. Participants will be asked to practice the yoga program daily at home
and will be given access to the yoga videos hosted on the University of Calgary study
website, as well as written program instructions, and frequently answered questions (Appendix
A). A brief description of the video content will be provided to inform the participant of
its content and length. Additional website content will include study information, study
schedule, and contact information, as well as a pre-recorded educational session.
In addition to the daily program describe above, the facilitator-led intervention will be
delivered online by a certified yoga facilitator using the Microsoft Teams platform.
Participants in group of 3 to 5 will be collated to enhance effectiveness of the study
processes. Our team has experience with this approach, as this strategy is currently used
with previous yoga study. Yoga classes will be held once per week for 8 weeks, with the first
session lasting approximately 1.5 hours and subsequent sessions up to 60 minutes. The total
allocated time for the introductory session will include the class set-up, introductions,
educational material (please see below), overview of practices, teaching of practices,
practice corrections/enhancements, modifications, and practice expectations. Each follow-up
class will include review from the previous week, questions and answers, individual
corrections and/or modifications. For individual corrections, the yoga facilitator will ask
the participant to do the practices and receive corrections, if needed.
Group 2. Advice-only control group. This group will receive general education on IBS, the
mind and gut connection, and the role of mind-body therapies in the management of IBS.
Educational Material. The intervention group will receive educational material consisting of
information on IBS, why yoga may improve IBS symptoms and quality of life, and
self-compassion (Appendix B) during their first online session delivered by the study
coordinator and yoga facilitator.
The study coordinator will orient each participant to the study, guide group 1 participants
through expectations of the class, answer any study-related questions for the duration of the
study. A study schedule will be provided to participants at the start of the study (Appendix
C). The yoga facilitator will act as a point of contact to answer any questions related to
the yoga program.
Practice Modifications. Intervention participants will receive modifications from the yoga
facilitator for common challenges encountered by yoga practitioners to support optimal
practices. Modifications will be provided in the online sessions.
Long-term follow-up. Yoga practice maintenance will be evaluated long-term. Intervention
participants will be asked to report the average frequency (i.e., days per month) and length
(i.e., minutes) of their yoga practices over the last 7 days at 6 months post intervention.
Feasibility outcomes. To determine the feasibility of each intervention, the following
outcomes will be evaluated: recruitment and attrition rates, adherence, and satisfaction, and
adverse event outcomes.
Sample size. 25 participants per group (mean difference of at least 83 points on the
IBS-Symptom Severity Scale; ⍺=0.05, β=0.80, SD=103.8, ∆=83)35. Assuming a 20% attrition rate,
we will aim to recruit 30 individuals per group.
Data Analysis. Descriptive analysis will summarize participant characteristics and
feasibility outcomes. Independent sample t-tests will examine baseline differences between
groups and chi-squared tests will examine proportion differences. Repeated measures ANOVA
will examine the main effect of treatment condition and interactions of group assignment by
time on effectiveness outcome measures. An alpha of 0.05 will be set a priori and used as a
threshold for determining statistical significance. Analysis will be conducted using SPSS
version 24.0.
For microbiome sequencing data quality control of raw FASTQ files will be performed, prior to
ML analysis, to obtain high-quality non-host (HQNH) reads. Reads of sufficient quality will
be mapped using MetaPhlAn2 and HUMAnN2 to obtain high-resolution taxonomic and functional
abundance profiles that include read counts. Unsupervised learning strategy based on robust
PCA will be used to explore the major variability in the data and to detect outliers. We will
also perform KEGG annotations and functional diversity profiling and will use web-based tools
to assign metagenomic results into different functional groups.
