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:

  1. Intervention Group - Medical Yoga, group treatment for eight weeks, 60 minutes per week, with the guidance of a physical therapist.

    or

  2. Control - treatment as usual (TAU) in physical therapy.

Study Overview

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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