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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2016
• Main ID: NCT02233114
• Date of registration: 25/08/2014
• Prospective Registration: Yes
• Primary sponsor: Karolinska Institutet
• Public title: Is Patients With Pulmonary Disease Benefit a Program With Yogic Exercises?
• Scientific title: Subjective and Objective Effects After Yogic Exercises
• Date of first enrolment: January 2015
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02233114
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Per Wändell, MD, PhD
• Affiliation: Karolinska Institutet, Stockholm

Key inclusion & exclusion criteria

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.



Age minimum: 35 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

COPD

Asthma

Intervention(s)

Other: Physiotherapy

Other: Yogic exercises

Primary Outcome(s)

Dyspnea related distress (DD) [Time Frame: Patients will be followed 10-12 weeks, with follow-up after 6 months]

Functional capacity [Time Frame: Patients will be followed 10-12 weeks, with follow-up after 6 months]

Secondary Outcome(s)

Health behaviour [Time Frame: Patients will be followed 10-12 weeks, with follow-up after 6 months]

Insomnia [Time Frame: Patients will be followed for 10-12 weeks, with follow-up after 6 months]

Spirometry, Forced expiratory volume in one second (FEV1) [Time Frame: Patients will be followed for 10-12 weeks, with follow-up after 6 months]

Subjective complaints (perceived symptoms) [Time Frame: Patients will be followed 10-12 weeks, with follow-up after 6 months]

Anxiety and depression [Time Frame: Patients will be followed 10-12 weeks, with follow-up after 6 months]

Heart rate variability [Time Frame: Patients will be followed for 10-12 weeks, with follow-up after 6 months]

Oxygen saturation (periphery) [Time Frame: Patients will be followed 10-12 weeks, with follow-up after 6 months]

VAS- scale - perceived health [Time Frame: Patients will be followed 10-12 weeks, with follow-up after 6 months]

Maximal inspiratory and maximal expiratory pressure [Time Frame: Patients will be followed 10-12 weeks, with follow-up after 6 months]

Spirometry, Forced expiratory volume [Time Frame: Patients will be followed for 10-12 weeks, with follow-up after 6 months]

Exercise diary [Time Frame: Patients will be followed 10-12 weeks, with follow-up after 6 months]

Respiration rate [Time Frame: Patients will be followed 10-12 weeks, with follow-up after 6 months]

Blood pressure [Time Frame: Patients will be followed 10-12 weeks, with follow-up after 6 months]

Sleep quality [Time Frame: Patients will be followed 10-12 weeks, with follow-up after 6 months]

Spirometry, Vital capacity [Time Frame: Patients will be followed 10-12 weeks, with follow-up after 6 months]

CRQ, Chronic respiratory disease questionnaire [Time Frame: Patients will be followed 10-12 weeks, with follow-up after 6 months]

Perceived stress [Time Frame: Patients will be followed 10-12 weeks, with follow-up after 6 months]

Qualitative content analysis [Time Frame: After Yoga intervention - one interview, with follow-up after 6 months]

Spirometry, peak expiratory flow (PEF) [Time Frame: Patients will be followed for 10-12 weeks, with follow-up after 6 months]

Self rated health [Time Frame: Patients will be followed 10-12 weeks, with follow-up after 6 months]

Spirometry, forced vital capacity (FVC) [Time Frame: 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 [Time Frame: Patients will be followed for 10-12 weeks, with follow-up after 6 months]

Weight and height [Time Frame: Patients will be followed 10-12 weeks, with follow-up after 6 months]

Secondary ID(s)

DNR2011/248-31/1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors