Is Patients With Pulmonary Disease Benefit a Program With Yogic Exercises?

Subjective and Objective Effects After Yogic Exercises

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.

Study Overview

• Status: Completed
• Conditions: Asthma; COPD
• Intervention / Treatment: Other: Yogic exercises; Other: Physiotherapy

Detailed Description

Is Yogic Exercises increasing respiratory function in patients with obstructive lung diseases. Will YE improve respiratory muscle strength, functional capacity, inspiratory and expiratory pressure, lung function, perceived dyspnea, dyspnea-related distress (DD), less frequency of dyspnea and heart rate variability in patients with pulmonary disease. Qualitative content analysis will be performed on approximately 15 interviews with patients participated in the yoga group about their experiences and their benefits perceived/experienced of the yogic exercises

We want to try YE as an alternative treatment in patients with mild to severe pulmonary disease.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Huddinge
    • Stockholm, Huddinge, Sweden
      • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yogic exercises; Yogic exercises for lung disorders	Other: Yogic exercises; Yogic exercises (YE) - 2 hours per week, 1h in each session
Active Comparator: physiotherapy; Physiotherapy during the yogic exercises	Other: Physiotherapy; Physiotherapy (low intensity cardiovascular training and strength training) - 2 hours per week, 1 h in each session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Measured manually	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	Scoring between 0 (worst possible) and 10 (best possible)	Patients will be followed 10-12 weeks, with follow-up after 6 months
Maximal inspiratory and maximal expiratory pressure		Patients will be followed 10-12 weeks, with follow-up after 6 months
Perceived stress	Will be measured using PSS-14 scale	Patients will be followed 10-12 weeks, with follow-up after 6 months
Sleep quality	Measured with Pittsburgh sleep questionnaire index scale	Patients will be followed 10-12 weeks, with follow-up after 6 months
Anxiety and depression	Measured with HADS-scale	Patients will be followed 10-12 weeks, with follow-up after 6 months
Self rated health		Patients will be followed 10-12 weeks, with follow-up after 6 months
Subjective complaints (perceived symptoms)		Patients will be followed 10-12 weeks, with follow-up after 6 months
Blood pressure		Patients will be followed 10-12 weeks, with follow-up after 6 months
Weight and height		Patients will be followed 10-12 weeks, with follow-up after 6 months
Health behaviour	Measured with public health questionnaire (Folkhälsoenkäten in Swedish)	Patients will be followed 10-12 weeks, with follow-up after 6 months
Exercise diary		Patients will be followed 10-12 weeks, with follow-up after 6 months
Spirometry, forced vital capacity (FVC)		Patients will be followed for 10-12 weeks, with follow-up after 6 months
Spirometry, Forced expiratory volume		Patients will be followed for 10-12 weeks, with follow-up after 6 months
Spirometry, Forced expiratory volume in one second (FEV1)		Patients will be followed for 10-12 weeks, with follow-up after 6 months
Spirometry, Ratio between forced expiratory volume in 1 second and forced vital capacity		Patients will be followed for 10-12 weeks, with follow-up after 6 months
Spirometry, peak expiratory flow (PEF)		Patients will be followed for 10-12 weeks, with follow-up after 6 months
Insomnia	Measured with insomnia index scale	Patients will be followed for 10-12 weeks, with follow-up after 6 months
Heart rate variability	Measured with Polar heart rate monitor	Patients will be followed for 10-12 weeks, with follow-up after 6 months
Qualitative content analysis	Inteviews with participants in yoga Group, and at follow-up also physiotherapy group	After Yoga intervention - one interview, with follow-up after 6 months

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Per Wändell, MD, PhD, Karolinska Institutet, Stockholm

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: August 25, 2014
• First Submitted That Met QC Criteria: September 5, 2014
• First Posted (Estimate): September 8, 2014

Study Record Updates

• Last Update Posted (Estimate): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 27, 2016
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: DNR2011/248-31/1