Pulmonary DiseaseMMforFANCT02612389
Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants
A study testing Meditative Movement taught via DVD in people with Pulmonary Disease and Autonomic Dysfunction, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This study will explore the a Qigong based exercise intervention, here referred to as Meditative Movement (MM), to ameliorate the symptoms associated with chronic obstructive pulmonary disease (COPD) and its co-morbidities. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Autonomic Dysfunction, COPD
- What is being tested?
- Meditative Movement taught via DVD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 17 Jul 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Occupation as a flight attendant for at least 5 years
- No history of significant tobacco use
- Occupational controls
Who cannot join
- Inability to give consent
- History of tobacco habituation
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
This study will explore the a Qigong based exercise intervention, here referred to as Meditative Movement (MM), to ameliorate the symptoms associated with chronic obstructive pulmonary disease (COPD) and its co-morbidities. It tests the hypothesis that MM will have a beneficial effect on COPD in FA, particularly on functional ability, respiratory symptoms, affective state, inflammation, and autonomic imbalance. If the hypothesis is correct, MM could be rapidly and inexpensively taught to FA with COPD and other COPD patients to slow degeneration and improve quality of life.
Read the detailed description
The study has three phases.
Phase 1 will identify the best MM practices and their impact on a test group of affected FA. Phase 2 will develop a video to apply what is learned in Phase 1 to a larger group of affected FA, and will document the resulting impact on various aspects of pulmonary dysfunction and its comorbidities. Phase 3 is to refine the protocols and methods developed in earlier phases.
Phase 1: To identify the best set of MM exercises for improving COPD-related symptoms. This will be done by conducting a 12-week in-person MM program that will be held in one or more locations in the Northeastern region of the US and possibly other regions of the country.These training sessions will be used to determine precisely which MM exercises are most appropriate for this group. Selection will be based on professional judgment, participant feedback, and objective pre- and post-intervention measurements taken at the beginning and end of the 12-week program.
Phase 2: To use an RCT to evaluate the effectiveness of the exercises selected in Aim 1, as delivered by video only. We will design and produce an instructional DVD based on the findings in Aim 1.In the RCT we will test the hypothesis that targeted MM training and practice using the DVD alone will improve QOL, exercise tolerance, autonomic balance and pulmonary function, and reduce fatigue, in flight attendants with a COPD diagnosis. Pre- and post-intervention measurements will be compared, and to outcomes from a control group of flight attendants who will be wait listed for later participation in the study.
Phase 3: The videos used to train subjects in Phase II will be refined and the order of introduction of training modules will be adjusted. Efficacy will again be tested in newly recruited subjects. This is also a RCT.
- Conditions
- Pulmonary Disease, Autonomic Dysfunction, COPD
- Being tested
- Meditative Movement taught via DVD
- Keywords
- COPD, Qigong, ANS, Meditative Movement, Flight Attendants, Secondhand Smoke, Nicotine, Blood Pressure, 6 minute walk test
- Medical subject headings
- Lung Diseases, Primary Dysautonomias, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meditative Movement taught via DVDOther
Also called Qigong
Gentle movement with attention to posture and breathing with emphasis on interoceptive awareness and self regulation.
| Study group | Role | What they receive |
|---|---|---|
| MM Intervention taught via DVD | Experimental | Receive Meditative Movement training via DVD with pre and post interventional testing. Receives: Other: Meditative Movement taught via DVD |
| MM Intervention Waitlist Control | No intervention | Testing at same frequency as Meditative Movement interventional subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6 minute walk test
Each participant walks as many ft as possible at a brisk pace. The amount of feet covered in 6 minutes is documented.
Measured: Baseline, 4 months
Change in C-reactive protein (CRP)
At each assessment circulating CRP will be monitored via blood collected in form of fingerstick.
Measured: Baseline, 4 months
Secondary outcomes (10)
Blood Pressure
Systolic and diastolic blood pressure, pre and post 6 minute walk test
Measured: Baseline, 4 months
Heart Rate
Heart rate measured pre and post 6 minute walk test
Measured: Baseline, 4 months
Oxygen Saturation
O2 saturation measured pre and post 6 minute walk test
Measured: Baseline, 4 months
Spirometry: FEV1/FVC
Spirometric measurement of FEV1/FVC administered using EasyOne Spirometer. FEV1/FVC is the ratio of Forced Expiratory Volume (1sec)/FVC (Forced Vital Capacity, (Expiratory))
Measured: Baseline, 4 months
Autonomic Function Self Report
Compass-31 administered via individual self-report.
Measured: Baseline, 4 months
Zung Anxiety Scale
Zung anxiety questionnaire administered via individual self report.
Measured: Baseline, 4 months
Zung Depression Scale
Zung depression questionnaire administered via individual self report.
Measured: Baseline, 4 months
Diurnal Salivary Cortisol
4 sputum samples collected from subjects
Measured: Baseline, 4 months
Melatonin
Melatonin levels from urine samples
Measured: Baseline, 4 months
Nicotine Exposure Autonomic Respiratory Syndrome (NEARS)
New questionnaire under evaluation to reflect autonomic influences on respiratory and other physiologic functions in nicotine exposed study population. Range and meaning of range are yet to be determined.
Measured: Baseline, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startMar 2015
- Primary completion17 Jun 2020
- Study completion17 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Flight Attendant Medical Research Institute, ZRT Laboratory, Norris Cotton Cancer Center
- Responsible party
- Principal investigator, Margaret A. Crane, Dartmouth-Hitchcock Medical Center
- Investigators
- Steven N Fiering, PhD, Principal investigator, Geisel School of Medicine, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612389
- Sponsor's protocol ID
- 28572
- Acronym
- MMforFA
- Status last verified
- Aug 2020
- First submitted
- 19 Nov 2015
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang L, Xu Y. Impact of Radiation Therapy on Outcomes of Artificial Urinary Sphincter: A Systematic Review and Meta-Analysis. Front Surg. 2022 Feb 14;9:825239. doi: 10.3389/fsurg.2022.825239. eCollection 2022.
PubMed 35237650Ye X, Gu Y, Bai Y, Xia S, Zhang Y, Lou Y, Zhu Y, Dai Y, Tsoi JK, Wang S. Does Low-Magnitude High-Frequency Vibration (LMHFV) Worth for Clinical Trial on Dental Implant? A Systematic Review and Meta-Analysis on Animal Studies. Front Bioeng Biotechnol. 2021 Apr 27;9:626892. doi: 10.3389/fbioe.2021.626892. eCollection 2021.
PubMed 33987172Payne P, Fiering S, Zava D, Gould TJ, Brown A, Hage P, Gaudet C, Crane-Godreau M. Digital Delivery of Meditative Movement Training Improved Health of Cigarette-Smoke-Exposed Subjects. Front Public Health. 2018 Oct 19;6:282. doi: 10.3389/fpubh.2018.00282. eCollection 2018.
PubMed 30406067Payne P, Fiering S, Leiter JC, Zava DT, Crane-Godreau MA. Effectiveness of a Novel Qigong Meditative Movement Practice for Impaired Health in Flight Attendants Exposed to Second-Hand Cigarette Smoke. Front Hum Neurosci. 2017 Feb 21;11:67. doi: 10.3389/fnhum.2017.00067. eCollection 2017.
PubMed 28270757Payne P, Zava D, Fiering S, Crane-Godreau M. Meditative Movement as a Treatment for Pulmonary Dysfunction in Flight Attendants Exposed to Second-Hand Cigarette Smoke: Study Protocol for a Randomized Trial. Front Psychiatry. 2016 Mar 22;7:38. doi: 10.3389/fpsyt.2016.00038. eCollection 2016.
PubMed 27047398
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants
- ClinicalTrials.gov ID
- NCT02612389
- Acronym / sponsor ID
- MMforFA / 28572
- Conditions
- Pulmonary Disease, Autonomic Dysfunction, COPD
- Keywords
- COPD, Qigong, ANS, Meditative Movement, Flight Attendants, Secondhand Smoke, Nicotine, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Flight Attendant Medical Research Institute, ZRT Laboratory, Norris Cotton Cancer Center
- Study start
- Mar 2015
- Primary completion
- 17 Jun 2020 (actual)
- Study completion
- 17 Jul 2020 (actual)
- First posted
- 23 Nov 2015 (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.
This study will explore the a Qigong based exercise intervention, here referred to as Meditative Movement (MM), to ameliorate the symptoms associated with chronic obstructive pulmonary disease (COPD) and its co-morbidities. It tests the hypothesis that MM will have a beneficial effect on COPD in FA, particularly on functional ability, respiratory symptoms, affective state, inflammation, and autonomic imbalance. If the hypothesis is correct, MM could be rapidly and inexpensively taught to FA with COPD and other COPD patients to slow degeneration and improve quality of life.
Detailed description
The study has three phases.
Phase 1 will identify the best MM practices and their impact on a test group of affected FA. Phase 2 will develop a video to apply what is learned in Phase 1 to a larger group of affected FA, and will document the resulting impact on various aspects of pulmonary dysfunction and its comorbidities. Phase 3 is to refine the protocols and methods developed in earlier phases.
Phase 1: To identify the best set of MM exercises for improving COPD-related symptoms. This will be done by conducting a 12-week in-person MM program that will be held in one or more locations in the Northeastern region of the US and possibly other regions of the country.These training sessions will be used to determine precisely which MM exercises are most appropriate for this group. Selection will be based on professional judgment, participant feedback, and objective pre- and post-intervention measurements taken at the beginning and end of the 12-week program.
Phase 2: To use an RCT to evaluate the effectiveness of the exercises selected in Aim 1, as delivered by video only. We will design and produce an instructional DVD based on the findings in Aim 1.In the RCT we will test the hypothesis that targeted MM training and practice using the DVD alone will improve QOL, exercise tolerance, autonomic balance and pulmonary function, and reduce fatigue, in flight attendants with a COPD diagnosis. Pre- and post-intervention measurements will be compared, and to outcomes from a control group of flight attendants who will be wait listed for later participation in the study.
Phase 3: The videos used to train subjects in Phase II will be refined and the order of introduction of training modules will be adjusted. Efficacy will again be tested in newly recruited subjects. This is also a RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MM Intervention taught via DVD | Experimental | Other: Meditative Movement taught via DVDReceive Meditative Movement training via DVD with pre and post interventional testing. |
| MM Intervention Waitlist Control | No intervention | –Testing at same frequency as Meditative Movement interventional subjects. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Occupation as a flight attendant for at least 5 years
- No history of significant tobacco use
- Occupational controls
Key exclusion criteria (2 listed)
- Inability to give consent
- History of tobacco habituation
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 |
|---|---|---|
| Meditative Movement taught via DVDAlso: QigongGentle movement with attention to posture and breathing with emphasis on interoceptive awareness and self regulation. | Other | MM Intervention taught via DVD |
Primary outcome
Change in 6 minute walk test
Time frame: Baseline, 4 months
Each participant walks as many ft as possible at a brisk pace. The amount of feet covered in 6 minutes is documented.
Change in C-reactive protein (CRP)
Time frame: Baseline, 4 months
At each assessment circulating CRP will be monitored via blood collected in form of fingerstick.
10 secondary outcomes
Blood Pressure
Time frame: Baseline, 4 months
Heart Rate
Time frame: Baseline, 4 months
Oxygen Saturation
Time frame: Baseline, 4 months
Spirometry: FEV1/FVC
Time frame: Baseline, 4 months
Autonomic Function Self Report
Time frame: Baseline, 4 months
Zung Anxiety Scale
Time frame: Baseline, 4 months
Zung Depression Scale
Time frame: Baseline, 4 months
Diurnal Salivary Cortisol
Time frame: Baseline, 4 months
Melatonin
Time frame: Baseline, 4 months
Nicotine Exposure Autonomic Respiratory Syndrome (NEARS)
Time frame: Baseline, 4 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 18 Aug 2020.
- Derived from this study: PubMed 35237650Zhang L, Xu Y. Impact of Radiation Therapy on Outcomes of Artificial Urinary Sphincter: A Systematic Review and Meta-Analysis. Front Surg. 2022 Feb 14;9:825239. doi: 10.3389/fsurg.2022.825239. eCollection 2022.
- Derived from this study: PubMed 33987172Ye X, Gu Y, Bai Y, Xia S, Zhang Y, Lou Y, Zhu Y, Dai Y, Tsoi JK, Wang S. Does Low-Magnitude High-Frequency Vibration (LMHFV) Worth for Clinical Trial on Dental Implant? A Systematic Review and Meta-Analysis on Animal Studies. Front Bioeng Biotechnol. 2021 Apr 27;9:626892. doi: 10.3389/fbioe.2021.626892. eCollection 2021.
- Derived from this study: PubMed 30406067Payne P, Fiering S, Zava D, Gould TJ, Brown A, Hage P, Gaudet C, Crane-Godreau M. Digital Delivery of Meditative Movement Training Improved Health of Cigarette-Smoke-Exposed Subjects. Front Public Health. 2018 Oct 19;6:282. doi: 10.3389/fpubh.2018.00282. eCollection 2018.
- Derived from this study: PubMed 28270757Payne P, Fiering S, Leiter JC, Zava DT, Crane-Godreau MA. Effectiveness of a Novel Qigong Meditative Movement Practice for Impaired Health in Flight Attendants Exposed to Second-Hand Cigarette Smoke. Front Hum Neurosci. 2017 Feb 21;11:67. doi: 10.3389/fnhum.2017.00067. eCollection 2017.
- Derived from this study: PubMed 27047398Payne P, Zava D, Fiering S, Crane-Godreau M. Meditative Movement as a Treatment for Pulmonary Dysfunction in Flight Attendants Exposed to Second-Hand Cigarette Smoke: Study Protocol for a Randomized Trial. Front Psychiatry. 2016 Mar 22;7:38. doi: 10.3389/fpsyt.2016.00038. eCollection 2016.
- Payne P, et al. (2016) Meditative Movement as a Treatment for Pulmonary Dysfunction in Flight Attendants Exposed to Second-Hand Cigarette Smoke: Study Protocol for a Randomized Trial. Front. Psychiatry 7:38. doi: 10.3389/fpsLink provided by the sponsor.
- Payne P, et al. (2017) Effectiveness of a Novel Qigong Meditative Movement Practice for Impaired Health in Flight Attendants Exposed to Second-Hand Cigarette Smoke. Front. Hum. Neurosci. 11:67. doi: 10.3389/fnhuLink provided by the sponsor.
- Payne P, Fiering S, Zava D, Gould TJ, Brown A, Hage P, Gaudet C and Crane-Godreau M (2018) Digital Delivery of Meditative Movement Training Improved Health of Cigarette-Smoke-Exposed Subjects. Front. Public Health 6:282. doi: 10.3389/fpubh.2018.00282Link provided by the sponsor.
- Website for Body Mind Science. Investigators are no longer at Dartmouth. Future publication links will be at the BodyMind Science sites.Link provided by the sponsor.
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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.
Steven N Fiering, PhD principal investigator
Geisel School of Medicine, Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditative Movement taught via DVD in people with Pulmonary Disease and Autonomic Dysfunction, run by Dartmouth-Hitchcock Medical Center at 1 site 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 3 inclusion and 2 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 18 Aug 2020. 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 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.
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?
Change in 6 minute walk test (time frame: Baseline, 4 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 NCT02612389, which also lists 5 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 18 Aug 2020.