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Medical Yoga for Patients With Stress-related Symptoms

This study is not yet open for participant recruitment.
Verified September 2016 by Maria Larsson, Vastra Gotaland Region
Sponsor:
ClinicalTrials.gov Identifier:
NCT02907138
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Maria Larsson, Vastra Gotaland Region
  Purpose

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.

Condition Intervention
Stress-related Illness/Anxiety Other: Medical Yoga Other: Treatment as Usual (physical therapy)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Maria Larsson, Vastra Gotaland Region:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Estimated Enrollment: 40
Study Start Date: September 2016
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medical Yoga
Medical Yoga Group therapy for eight weeks, 60 minutes per week, with the guidance of a physical therapist.
Other: Medical Yoga
Active Comparator: Treatment as Usual (physical therapy)
Treatment as Usual provided by physical therapist
Other: Treatment as Usual (physical therapy)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907138


Contacts
Contact: Maria EH Larsson, Assoc Prof +46767905400 maria.eh.larsson@vgregion.se

Sponsors and Collaborators
Maria Larsson
  More Information

Responsible Party: Maria Larsson, Assoc. professor, Research and Development director, Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT02907138     History of Changes
Other Study ID Numbers: VGFOUGSB-602221
First Submitted: September 9, 2016
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
Last Verified: September 2016