Clinical trial NCT02233114: Is Patients With Pulmonary Disease Benefit a Program With Yogic Exercises?
Official title: Subjective and Objective Effects After Yogic Exercises
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Asthma
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2014-09-08
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Dyspnea related distress (DD)
timeFrame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Functional capacity
timeFrame: Patients will be followed 10-12 weeks, with follow-up after 6 months
Secondary outcomes:
measure: Spirometry, Vital capacity
timeFrame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Oxygen saturation (periphery)
timeFrame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Respiration rate
timeFrame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: CRQ, Chronic respiratory disease questionnaire
timeFrame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: VAS- scale - perceived health
timeFrame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Maximal inspiratory and maximal expiratory pressure
timeFrame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Perceived stress
timeFrame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Sleep quality
timeFrame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Anxiety and depression
timeFrame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Self rated health
timeFrame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Subjective complaints (perceived symptoms)
timeFrame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Blood pressure
timeFrame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Weight and height
timeFrame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Health behaviour
timeFrame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Exercise diary
timeFrame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Spirometry, forced vital capacity (FVC)
timeFrame: Patients will be followed for 10-12 weeks, with follow-up after 6 months
measure: Spirometry, Forced expiratory volume
timeFrame: Patients will be followed for 10-12 weeks, with follow-up after 6 months
measure: Spirometry, Forced expiratory volume in one second (FEV1)
timeFrame: Patients will be followed for 10-12 weeks, with follow-up after 6 months
measure: Spirometry, Ratio between forced expiratory volume in 1 second and forced vital capacity
timeFrame: Patients will be followed for 10-12 weeks, with follow-up after 6 months
measure: Spirometry, peak expiratory flow (PEF)
timeFrame: Patients will be followed for 10-12 weeks, with follow-up after 6 months
measure: Insomnia
timeFrame: Patients will be followed for 10-12 weeks, with follow-up after 6 months
measure: Heart rate variability
timeFrame: Patients will be followed for 10-12 weeks, with follow-up after 6 months
measure: Qualitative content analysis
timeFrame: After Yoga intervention - one interview, with follow-up after 6 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University hospital
state: Huddinge
Study officials:
affiliation: Karolinska Institutet, Stockholm
name: Per Wändell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.