- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02907138
Medical Yoga for Patients With Stress-related Symptoms
September 13, 2020 updated by: Maria Larsson
The purpose of this study is to compare the effect of Medical Yoga as a group treatment, to conventional treatment provided by a physical therapist, for people with perceived stress-related symptoms.
Forty people are to be randomized to either:
Intervention Group - Medical Yoga, group treatment for eight weeks, 60 minutes per week, with the guidance of a physical therapist.
or
- Control - treatment as usual (TAU) in physical therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Gothenburg, Sweden
- Närhälsan Gibraltar Rehabmottagning
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Perceived stress and anxiety, which could be expressed as for example as tension in the neck and shoulders, insomnia, anxiety and headaches.
Exclusion Criteria:
- Do not understand Swedish (as group instructions need to be understood),
- Pregnancy,
- Psychotic symptoms,
- Ongoing or physical therapy treatment the last three months,
- Previously participated in Medical Yoga group.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Medical Yoga
Medical Yoga Group therapy for eight weeks, 60 minutes per week, with the guidance of a physical therapist.
|
|
Active Comparator: Treatment as Usual (physical therapy)
Treatment as Usual provided by physical therapist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Stress Scale (PSS)
Time Frame: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
|
Outcome will be measured as change between baseline and follow-ups and between follow-ups.
Total score will also be analysed between groups at follow-up(s).
|
baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
|
baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
|
Health-related quality of Life; EQ5D
Time Frame: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
|
baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
|
Thorax excursion: Measured in centimeters with tape measure, chest size at the level of processus xiphoideus, the difference between the maximum inhalation and exhalation is registered
Time Frame: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
|
baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
|
Health-related quality of Life; EQ-VAS
Time Frame: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
|
baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Actual)
February 15, 2019
Study Completion (Actual)
March 4, 2019
Study Registration Dates
First Submitted
September 9, 2016
First Submitted That Met QC Criteria
September 19, 2016
First Posted (Estimate)
September 20, 2016
Study Record Updates
Last Update Posted (Actual)
September 16, 2020
Last Update Submitted That Met QC Criteria
September 13, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- VGFOUGSB-602221
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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