NCT02233114

Brief Summary

Is Yogic Exercises (12 weeks) increasing respiratory function, functional capacity and quality of life in patients with obstructive lung diseases. With follow up after 6 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

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

First Submitted

Initial submission to the registry

August 25, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 8, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 28, 2016

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

August 25, 2014

Last Update Submit

January 27, 2016

Conditions

COPDAsthma

Outcome Measures

Primary Outcomes (2)

  • Dyspnea related distress (DD)

    Patients will be followed 10-12 weeks, with follow-up after 6 months

  • Functional capacity

    6 minutes Walking test

    Patients will be followed 10-12 weeks, with follow-up after 6 months

Secondary Outcomes (23)

  • Spirometry, Vital capacity

    Patients will be followed 10-12 weeks, with follow-up after 6 months

  • Oxygen saturation (periphery)

    Patients will be followed 10-12 weeks, with follow-up after 6 months

  • Respiration rate

    Patients will be followed 10-12 weeks, with follow-up after 6 months

  • CRQ, Chronic respiratory disease questionnaire

    Patients will be followed 10-12 weeks, with follow-up after 6 months

  • VAS- scale - perceived health

    Patients will be followed 10-12 weeks, with follow-up after 6 months

  • +18 more secondary outcomes

Study Arms (2)

Yogic exercises

EXPERIMENTAL

Yogic exercises for lung disorders

Other: Yogic exercises

physiotherapy

ACTIVE COMPARATOR

Physiotherapy during the yogic exercises

Other: Physiotherapy

Interventions

Yogic exercisesOTHER

Yogic exercises (YE) - 2 hours per week, 1h in each session

Yogic exercises
PhysiotherapyOTHER

Physiotherapy (low intensity cardiovascular training and strength training) - 2 hours per week, 1 h in each session

physiotherapy

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mild to severe pulmonary obstructions according to GOLD 1-3 (Global Initiative for Chronic Obstructive Lung Disease),
  • FEV (forced expiratory volume) in one second (FEV1) % of predicted respiratory function (30% ≤ FEV1 ≤ 90%)
  • FEV1/FVC \< 0.70 (\<65 over 65 yrs). \*FVC=forced vital capacity

You may not qualify if:

  • Severe neurological, orthopedic or rheumatologic injuries
  • Severely decreased thorax mobility and lung function.
  • Severe lung diseases
  • Other chronic diseases that will interfere with performance.
  • Under 200 meters on the 6MWT
  • Acute dyspnea
  • Surgery within 6 months
  • Medication affecting attention, sudden change of medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University hospital

Stockholm, Huddinge, Sweden

Location

Related Publications (1)

  • Papp ME, Henriques M, Biguet G, Wandell PE, Nygren-Bonnier M. Experiences of hatha yogic exercises among patients with obstructive pulmonary diseases: A qualitative study. J Bodyw Mov Ther. 2018 Oct;22(4):896-903. doi: 10.1016/j.jbmt.2017.11.001. Epub 2017 Nov 8.

    PMID: 30368332DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAsthma

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Per Wändell, MD, PhD

    Karolinska Institutet, Stockholm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 25, 2014

First Posted

September 8, 2014

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 28, 2016

Record last verified: 2015-09

Locations

SE(1)