NCT02907138

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. 1.Intervention Group - Medical Yoga, group treatment for eight weeks, 60 minutes per week, with the guidance of a physical therapist.
  2. 2.Control - treatment as usual (TAU) in physical therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2019

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2019

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

2.5 years

First QC Date

September 9, 2016

Last Update Submit

September 13, 2020

Conditions

Stress-related Illness/Anxiety

Outcome Measures

Primary Outcomes (1)

  • Perceived Stress Scale (PSS)

    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 Outcomes (4)

  • Hospital Anxiety and Depression Scale (HADS)

    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

    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

    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

    baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session

Study Arms (2)

Medical Yoga

EXPERIMENTAL

Medical Yoga Group therapy for eight weeks, 60 minutes per week, with the guidance of a physical therapist.

Other: Medical Yoga

Treatment as Usual (physical therapy)

ACTIVE COMPARATOR

Treatment as Usual provided by physical therapist

Other: Treatment as Usual (physical therapy)

Interventions

Medical YogaOTHER
Medical Yoga
Treatment as Usual (physical therapy)OTHER
Treatment as Usual (physical therapy)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Perceived stress and anxiety, which could be expressed as for example as tension in the neck and shoulders, insomnia, anxiety and headaches.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Narhalsan Gibraltar rehabmottagning

Gothenburg, Sweden

Location

Related Publications (1)

  • Bellfjord M, Grimby-Ekman A, Larsson MEH. MediYoga compared to physiotherapy treatment as usual for patients with stress-related symptoms in primary care rehabilitation: A randomized controlled trial. PLoS One. 2024 Jun 13;19(6):e0300756. doi: 10.1371/journal.pone.0300756. eCollection 2024.

    PMID: 38870156DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

TherapeuticsPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. professor, Research and Development director

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 20, 2016

Study Start

September 1, 2016

Primary Completion

February 15, 2019

Study Completion

March 4, 2019

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations

SE(1)