ClinicalTrials.gov
ClinicalTrials.gov Menu

Medical Yoga for Patients With Stress-related Symptoms

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.
ClinicalTrials.gov Identifier: NCT02907138
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Maria Larsson, Vastra Gotaland Region

Brief Summary:

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 or disease Intervention/treatment Phase
Stress-related Illness/Anxiety Other: Medical Yoga Other: Treatment as Usual (physical therapy) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
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.

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

Locations
Sweden
Narhalsan Gibraltar rehabmottagning Recruiting
Gothenburg, Sweden
Contact: Madeleine Bellfjord         
Sponsors and Collaborators
Maria Larsson

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 Posted: September 20, 2016    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018