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

Asthma Clinical Trial

Official title:

Subjective and Objective Effects After Yogic Exercises

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233114
• Other study ID #: DNR2011/248-31/1
• Status: Completed
• Phase: N/A
• First received: August 25, 2014
• Last updated: January 27, 2016
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: September 2015
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asthma
• COPD

Intervention

Other:
• Yogic exercises
Yogic exercises (YE) - 2 hours per week, 1h in each session
• Physiotherapy
Physiotherapy (low intensity cardiovascular training and strength training) - 2 hours per week, 1 h in each session

Locations

Country	Name	City	State
Sweden	Karolinska University hospital	Stockholm	Huddinge

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyspnea related distress (DD)		Patients will be followed 10-12 weeks, with follow-up after 6 months	No
Primary	Functional capacity	6 minutes Walking test	Patients will be followed 10-12 weeks, with follow-up after 6 months	No
Secondary	Spirometry, Vital capacity		Patients will be followed 10-12 weeks, with follow-up after 6 months	No
Secondary	Oxygen saturation (periphery)		Patients will be followed 10-12 weeks, with follow-up after 6 months	No
Secondary	Respiration rate	Measured manually	Patients will be followed 10-12 weeks, with follow-up after 6 months	No
Secondary	CRQ, Chronic respiratory disease questionnaire		Patients will be followed 10-12 weeks, with follow-up after 6 months	No
Secondary	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	No
Secondary	Maximal inspiratory and maximal expiratory pressure		Patients will be followed 10-12 weeks, with follow-up after 6 months	No
Secondary	Perceived stress	Will be measured using PSS-14 scale	Patients will be followed 10-12 weeks, with follow-up after 6 months	No
Secondary	Sleep quality	Measured with Pittsburgh sleep questionnaire index scale	Patients will be followed 10-12 weeks, with follow-up after 6 months	No
Secondary	Anxiety and depression	Measured with HADS-scale	Patients will be followed 10-12 weeks, with follow-up after 6 months	No
Secondary	Self rated health		Patients will be followed 10-12 weeks, with follow-up after 6 months	No
Secondary	Subjective complaints (perceived symptoms)		Patients will be followed 10-12 weeks, with follow-up after 6 months	No
Secondary	Blood pressure		Patients will be followed 10-12 weeks, with follow-up after 6 months	No
Secondary	Weight and height		Patients will be followed 10-12 weeks, with follow-up after 6 months	No
Secondary	Health behaviour	Measured with public health questionnaire (Folkhälsoenkäten in Swedish)	Patients will be followed 10-12 weeks, with follow-up after 6 months	No
Secondary	Exercise diary		Patients will be followed 10-12 weeks, with follow-up after 6 months	No
Secondary	Spirometry, forced vital capacity (FVC)		Patients will be followed for 10-12 weeks, with follow-up after 6 months	No
Secondary	Spirometry, Forced expiratory volume		Patients will be followed for 10-12 weeks, with follow-up after 6 months	No
Secondary	Spirometry, Forced expiratory volume in one second (FEV1)		Patients will be followed for 10-12 weeks, with follow-up after 6 months	No
Secondary	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	No
Secondary	Spirometry, peak expiratory flow (PEF)		Patients will be followed for 10-12 weeks, with follow-up after 6 months	No
Secondary	Insomnia	Measured with insomnia index scale	Patients will be followed for 10-12 weeks, with follow-up after 6 months	No
Secondary	Heart rate variability	Measured with Polar heart rate monitor	Patients will be followed for 10-12 weeks, with follow-up after 6 months	No
Secondary	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	No