Chronic Obstructive Pulmonary Disease (COPD)Phase 2BEAM COPDNCT01551953
BEAM COPD: Breathing, Education, Awareness and Movement in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing Tai chi, Mind-body breathing and Education in people with Chronic Obstructive Pulmonary Disease (COPD), run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial summary
The main purpose of this study is to determine feasibility and effects of tai chi and mind-body breathing in patients with COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Tai chi, Mind-body breathing and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2011to Apr 2016
- Phase
- Phase 2
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate-severe COPD
- Age ≥ 40 years
Who cannot join
- Subjects with respiratory failure or GOLD stage 4 who are unable to safely perform a 6 minute walk test or otherwise safely exercise as deemed by a physician.
- COPD exacerbation requiring steroids, antibiotics, ED visit or hospitalization within the past 2 weeks unless physician deems subject at baseline
- Planned major pulmonary intervention within the next 3 months
- Hypoxemia on walk test or cardiopulmonary exercise test
- Inability to ambulate due to vascular or other neuromuscular conditions that would preclude a walk test
- Clinical signs of unstable cardiovascular disease
Show all 11Show fewer
- Severe cognitive dysfunction
- Non-English speaking
- Current active participation in pulmonary rehabilitation program or current regular practice of tai chi
- Physician diagnosis of unstable/untreated clinical depression
- History of lung cancer
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Healthcare System
Boston, Massachusetts, 02130
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: BEAM COPD: Breathing, Education, Awareness and Movement in Chronic Obstructive Pulmonary Disease
The main purpose of this study is to determine feasibility and effects of tai chi and mind-body breathing in patients with COPD.
- Being tested
- Tai chi, Mind-body breathing, Education
- Keywords
- chronic bronchitis, emphysema, pulmonary, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai chiBehavioural
12 week tai chi class
Mind-body breathingBehavioural
12 week breathing class
EducationBehavioural
12 week education class
| Study group | Role | What they receive |
|---|---|---|
| tai chi exercise | Experimental | Not described Receives: Behavioral: Tai chi |
| mind-body breathing | Experimental | Not described Receives: Behavioral: Mind-body breathing |
| education | Active comparator | Not described Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of tai chi intervention
Willingness to participate, adherence, and safety
Measured: 12 weeks
Secondary outcomes (6)
Change from baseline- Disease specific quality of life
Chronic Respiratory Questionnaire
Measured: baseline, 12 weeks, 24 weeks
Change from baseline- Exercise capacity
six-minute walk distance, cardiopulmonary exercise testing
Measured: baseline, 12 weeks, 24 weeks
Change from baseline- Dyspnea
UCSD Shortness of Breath Questionnaire
Measured: baseline, 12 weeks, 24 weeks
Change from baseline- Psychosocial well-being
CES-D, Perceive Stress Scale, COPD Self-Efficacy Scale, Multidimensional Scale of Percieved Social Support
Measured: baseline, 12 weeks, 24 weeks
Change from baseline- Pulmonary function
Spirometry and lung volumes
Measured: baseline, 12 weeks, 24 weeks
Change from baseline- Physical strength and flexibility
Chair Sit and Reach, Chair Stand
Measured: baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startFeb 2011
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Gloria Y. Yeh, Beth Israel Deaconess Medical Center
- Investigators
- Gloria Yeh, MD, MPH, Principal investigator, BIDMC, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551953
- Sponsor's protocol ID
- 2010P000412
- Other IDs
- R01AT005436
- Acronym
- BEAM COPD
- Status last verified
- Feb 2017
- First submitted
- 1 Mar 2012
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kraemer KM, Kilgore K, Litrownik D, Jean-Laurent B, Wayne PM, Richardson CR, Moy ML, Yeh GY. A Web-Based Mind-Body Intervention (Mindful Steps) for Promoting Walking in Chronic Cardiopulmonary Disease: Insights From a Qualitative Study. Glob Adv Integr Med Health. 2023 Dec 2;12:27536130231212169. doi: 10.1177/27536130231212169. eCollection 2023 Jan-Dec.
PubMed 38050584Gilliam EA, Cheung T, Kraemer K, Litrownik D, Wayne PM, Moy ML, Yeh GY. The impact of Tai Chi and mind-body breathing in COPD: Insights from a qualitative sub-study of a randomized controlled trial. PLoS One. 2021 Apr 8;16(4):e0249263. doi: 10.1371/journal.pone.0249263. eCollection 2021.
PubMed 33831022Yeh GY, Litrownik D, Wayne PM, Beach D, Klings ES, Reyes Nieva H, Pinheiro A, Davis RB, Moy ML. BEAM study (Breathing, Education, Awareness, Movement): a randomised controlled feasibility trial of tai chi exercise in patients with COPD. BMJ Open Respir Res. 2020 Nov;7(1):e000697. doi: 10.1136/bmjresp-2020-000697.
PubMed 33219007Yeh GY, Wayne PM, Litrownik D, Roberts DH, Davis RB, Moy ML. Tai chi mind-body exercise in patients with COPD: study protocol for a randomized controlled trial. Trials. 2014 Aug 28;15:337. doi: 10.1186/1745-6215-15-337.
PubMed 25168853
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEAM COPD: Breathing, Education, Awareness and Movement in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01551953
- Acronym / sponsor ID
- BEAM COPD / 2010P000412
- Keywords
- chronic bronchitis, emphysema, pulmonary, COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Feb 2011
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 Mar 2012 (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.
The main purpose of this study is to determine feasibility and effects of tai chi and mind-body breathing in patients with COPD.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tai chi exercise | Experimental | Behavioral: Tai chi |
| mind-body breathing | Experimental | Behavioral: Mind-body breathing |
| education | Active comparator | Behavioral: Education |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate-severe COPD
- Age ≥ 40 years
Key exclusion criteria (11 listed)
- Subjects with respiratory failure or GOLD stage 4 who are unable to safely perform a 6 minute walk test or otherwise safely exercise as deemed by a physician.
- COPD exacerbation requiring steroids, antibiotics, ED visit or hospitalization within the past 2 weeks unless physician deems subject at baseline
- Planned major pulmonary intervention within the next 3 months
- Hypoxemia on walk test or cardiopulmonary exercise test
- Inability to ambulate due to vascular or other neuromuscular conditions that would preclude a walk test
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 |
|---|---|---|
| Tai chi12 week tai chi class | Behavioural | tai chi exercise |
| Mind-body breathing12 week breathing class | Behavioural | mind-body breathing |
| Education12 week education class | Behavioural | education |
Primary outcome
Feasibility of tai chi intervention
Time frame: 12 weeks
Willingness to participate, adherence, and safety
6 secondary outcomes
Change from baseline- Disease specific quality of life
Time frame: baseline, 12 weeks, 24 weeks
Change from baseline- Exercise capacity
Time frame: baseline, 12 weeks, 24 weeks
Change from baseline- Dyspnea
Time frame: baseline, 12 weeks, 24 weeks
Change from baseline- Psychosocial well-being
Time frame: baseline, 12 weeks, 24 weeks
Change from baseline- Pulmonary function
Time frame: baseline, 12 weeks, 24 weeks
Change from baseline- Physical strength and flexibility
Time frame: baseline, 12 weeks, 24 weeks
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 27 Feb 2017.
- Derived from this study: PubMed 38050584Kraemer KM, Kilgore K, Litrownik D, Jean-Laurent B, Wayne PM, Richardson CR, Moy ML, Yeh GY. A Web-Based Mind-Body Intervention (Mindful Steps) for Promoting Walking in Chronic Cardiopulmonary Disease: Insights From a Qualitative Study. Glob Adv Integr Med Health. 2023 Dec 2;12:27536130231212169. doi: 10.1177/27536130231212169. eCollection 2023 Jan-Dec.
- Derived from this study: PubMed 33831022Gilliam EA, Cheung T, Kraemer K, Litrownik D, Wayne PM, Moy ML, Yeh GY. The impact of Tai Chi and mind-body breathing in COPD: Insights from a qualitative sub-study of a randomized controlled trial. PLoS One. 2021 Apr 8;16(4):e0249263. doi: 10.1371/journal.pone.0249263. eCollection 2021.
- Derived from this study: PubMed 33219007Yeh GY, Litrownik D, Wayne PM, Beach D, Klings ES, Reyes Nieva H, Pinheiro A, Davis RB, Moy ML. BEAM study (Breathing, Education, Awareness, Movement): a randomised controlled feasibility trial of tai chi exercise in patients with COPD. BMJ Open Respir Res. 2020 Nov;7(1):e000697. doi: 10.1136/bmjresp-2020-000697.
- Derived from this study: PubMed 25168853Yeh GY, Wayne PM, Litrownik D, Roberts DH, Davis RB, Moy ML. Tai chi mind-body exercise in patients with COPD: study protocol for a randomized controlled trial. Trials. 2014 Aug 28;15:337. doi: 10.1186/1745-6215-15-337.
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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.
Gloria Yeh, MD, MPH principal investigator
BIDMC, Harvard Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tai chi, Mind-body breathing and Education in people with Chronic Obstructive Pulmonary Disease (COPD), run by Beth Israel Deaconess Medical Center at 2 sites in United States.
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 2 inclusion and 11 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 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility of tai chi intervention (time frame: 12 weeks). 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 NCT01551953, which also lists 4 linked publications.
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 27 Feb 2017.