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Completed

NCT Number: NCT02233114

Is Patients With Pulmonary Disease Benefit a Program With 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.

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Key information

Conditions

COPD Asthma Bronchial Diseases Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University hospital

Stockholm, Huddinge, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yogic exercises

Other

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

Physiotherapy

Other

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

Primary outcomes

  1. Dyspnea related distress (DD)

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

  2. Functional capacity

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

    6 minutes Walking test

Secondary outcomes

  1. Spirometry, Vital capacity

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

  2. Oxygen saturation (periphery)

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

  3. Respiration rate

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

    Measured manually

  4. CRQ, Chronic respiratory disease questionnaire

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

  5. VAS- scale - perceived health

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

    Scoring between 0 (worst possible) and 10 (best possible)

  6. Maximal inspiratory and maximal expiratory pressure

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

  7. Perceived stress

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

    Will be measured using PSS-14 scale

  8. Sleep quality

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

    Measured with Pittsburgh sleep questionnaire index scale

  9. Anxiety and depression

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

    Measured with HADS-scale

  10. Self rated health

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

  11. Subjective complaints (perceived symptoms)

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

  12. Blood pressure

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

  13. Weight and height

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

  14. Health behaviour

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

    Measured with public health questionnaire (Folkhälsoenkäten in Swedish)

  15. Exercise diary

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

  16. Spirometry, forced vital capacity (FVC)

    Time frame: Patients will be followed for 10-12 weeks, with follow-up after 6 months

  17. Spirometry, Forced expiratory volume

    Time frame: Patients will be followed for 10-12 weeks, with follow-up after 6 months

  18. Spirometry, Forced expiratory volume in one second (FEV1)

    Time frame: Patients will be followed for 10-12 weeks, with follow-up after 6 months

  19. 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

  20. Spirometry, peak expiratory flow (PEF)

    Time frame: Patients will be followed for 10-12 weeks, with follow-up after 6 months

  21. Insomnia

    Time frame: Patients will be followed for 10-12 weeks, with follow-up after 6 months

    Measured with insomnia index scale

  22. Heart rate variability

    Time frame: Patients will be followed for 10-12 weeks, with follow-up after 6 months

    Measured with Polar heart rate monitor

  23. Qualitative content analysis

    Time frame: After Yoga intervention - one interview, with follow-up after 6 months

    Inteviews with participants in yoga Group, and at follow-up also physiotherapy group

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Subjective and Objective Effects After Yogic Exercises

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 8, 2014
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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