COPDNCT02233114
Is Patients With Pulmonary Disease Benefit a Program With Yogic Exercises?
A study testing Yogic exercises and Physiotherapy in people with COPD and Asthma, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- What is being tested?
- Yogic exercises and Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Yogic exercises, Physiotherapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yogic exercisesOther
Yogic exercises (YE) - 2 hours per week, 1h in each session
PhysiotherapyOther
Physiotherapy (low intensity cardiovascular training and strength training) - 2 hours per week, 1 h in each session
| Study group | Role | What they receive |
|---|---|---|
| Yogic exercises | Experimental | Yogic exercises for lung disorders Receives: Other: Yogic exercises |
| physiotherapy | Active comparator | Physiotherapy during the yogic exercises Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea related distress (DD)
Measured: Patients will be followed 10-12 weeks, with follow-up after 6 months
Functional capacity
6 minutes Walking test
Measured: Patients will be followed 10-12 weeks, with follow-up after 6 months
Secondary outcomes (23)
Spirometry, Vital capacity
Measured: Patients will be followed 10-12 weeks, with follow-up after 6 months
Oxygen saturation (periphery)
Measured: Patients will be followed 10-12 weeks, with follow-up after 6 months
Respiration rate
Measured manually
Measured: Patients will be followed 10-12 weeks, with follow-up after 6 months
CRQ, Chronic respiratory disease questionnaire
Measured: 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)
Measured: Patients will be followed 10-12 weeks, with follow-up after 6 months
Maximal inspiratory and maximal expiratory pressure
Measured: Patients will be followed 10-12 weeks, with follow-up after 6 months
Perceived stress
Will be measured using PSS-14 scale
Measured: Patients will be followed 10-12 weeks, with follow-up after 6 months
Sleep quality
Measured with Pittsburgh sleep questionnaire index scale
Measured: Patients will be followed 10-12 weeks, with follow-up after 6 months
Anxiety and depression
Measured with HADS-scale
Measured: Patients will be followed 10-12 weeks, with follow-up after 6 months
Self rated health
Measured: Patients will be followed 10-12 weeks, with follow-up after 6 months
Subjective complaints (perceived symptoms)
Measured: Patients will be followed 10-12 weeks, with follow-up after 6 months
Blood pressure
Measured: Patients will be followed 10-12 weeks, with follow-up after 6 months
Weight and height
Measured: Patients will be followed 10-12 weeks, with follow-up after 6 months
Health behaviour
Measured with public health questionnaire (Folkhälsoenkäten in Swedish)
Measured: Patients will be followed 10-12 weeks, with follow-up after 6 months
Exercise diary
Measured: Patients will be followed 10-12 weeks, with follow-up after 6 months
Spirometry, forced vital capacity (FVC)
Measured: Patients will be followed for 10-12 weeks, with follow-up after 6 months
Spirometry, Forced expiratory volume
Measured: Patients will be followed for 10-12 weeks, with follow-up after 6 months
Spirometry, Forced expiratory volume in one second (FEV1)
Measured: 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
Measured: Patients will be followed for 10-12 weeks, with follow-up after 6 months
Spirometry, peak expiratory flow (PEF)
Measured: Patients will be followed for 10-12 weeks, with follow-up after 6 months
Insomnia
Measured with insomnia index scale
Measured: Patients will be followed for 10-12 weeks, with follow-up after 6 months
Heart rate variability
Measured with Polar heart rate monitor
Measured: 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
Measured: After Yoga intervention - one interview, with follow-up after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Wandell, Karolinska Institutet
- Investigators
- Per Wändell, MD, PhD, Principal investigator, Karolinska Institutet, Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233114
- Sponsor's protocol ID
- DNR2011/248-31/1
- Status last verified
- Sep 2015
- First submitted
- 25 Aug 2014
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 30368332
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjective and Objective Effects After Yogic Exercises
- ClinicalTrials.gov ID
- NCT02233114
- Acronym / sponsor ID
- DNR2011/248-31/1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yogic exercises | Experimental | Other: Yogic exercisesYogic exercises for lung disorders |
| physiotherapy | Active comparator | Other: PhysiotherapyPhysiotherapy during the yogic exercises |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yogic exercisesYogic exercises (YE) - 2 hours per week, 1h in each session | Other | Yogic exercises |
| PhysiotherapyPhysiotherapy (low intensity cardiovascular training and strength training) - 2 hours per week, 1 h in each session | Other | physiotherapy |
Primary outcome
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
6 minutes Walking test
23 secondary outcomes
Spirometry, Vital capacity
Time frame: Patients will be followed 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
Respiration rate
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
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
Perceived stress
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
Anxiety and depression
Time frame: Patients will be followed 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
Subjective complaints (perceived symptoms)
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
Weight and height
Time frame: Patients will be followed 10-12 weeks, with follow-up after 6 months
Health behaviour
Time frame: Patients will be followed 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
Spirometry, forced vital capacity (FVC)
Time frame: Patients will be followed for 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
Spirometry, Forced expiratory volume in one second (FEV1)
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
Spirometry, peak expiratory flow (PEF)
Time frame: Patients will be followed for 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
Heart rate variability
Time frame: Patients will be followed for 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Derived from this study: PubMed 30368332Papp 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Wändell, MD, PhD principal investigator
Karolinska Institutet, Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yogic exercises and Physiotherapy in people with COPD and Asthma, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea related distress (DD) (time frame: Patients will be followed 10-12 weeks, with follow-up after 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02233114, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.