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Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants (MMforFA)

Primary Purpose

Pulmonary Disease, Autonomic Dysfunction, COPD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meditative Movement taught via DVD
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease focused on measuring COPD, Qigong, ANS, Meditative Movement, Flight Attendants, Secondhand Smoke, Nicotine, Blood Pressure, 6 minute walk test

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Occupation as a flight attendant for at least 5 years
  • No history of significant tobacco use
  • Occupational controls

Exclusion Criteria:

  • Inability to give consent
  • History of tobacco habituation

Sites / Locations

  • Dartmouth Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MM Intervention taught via DVD

MM Intervention Waitlist Control

Arm Description

Receive Meditative Movement training via DVD with pre and post interventional testing.

Testing at same frequency as Meditative Movement interventional subjects.

Outcomes

Primary Outcome Measures

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.
Change in C-reactive protein (CRP)
At each assessment circulating CRP will be monitored via blood collected in form of fingerstick.

Secondary Outcome Measures

Blood Pressure
Systolic and diastolic blood pressure, pre and post 6 minute walk test
Heart Rate
Heart rate measured pre and post 6 minute walk test
Oxygen Saturation
O2 saturation measured pre and post 6 minute walk test
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))
Autonomic Function Self Report
Compass-31 administered via individual self-report.
Zung Anxiety Scale
Zung anxiety questionnaire administered via individual self report.
Zung Depression Scale
Zung depression questionnaire administered via individual self report.
Diurnal Salivary Cortisol
4 sputum samples collected from subjects
Melatonin
Melatonin levels from urine samples
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.

Full Information

First Posted
November 19, 2015
Last Updated
August 14, 2020
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Flight Attendant Medical Research Institute, ZRT Laboratory, Norris Cotton Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02612389
Brief Title
Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants
Acronym
MMforFA
Official Title
Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 17, 2020 (Actual)
Study Completion Date
July 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Flight Attendant Medical Research Institute, ZRT Laboratory, Norris Cotton Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Autonomic Dysfunction, COPD
Keywords
COPD, Qigong, ANS, Meditative Movement, Flight Attendants, Secondhand Smoke, Nicotine, Blood Pressure, 6 minute walk test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MM Intervention taught via DVD
Arm Type
Experimental
Arm Description
Receive Meditative Movement training via DVD with pre and post interventional testing.
Arm Title
MM Intervention Waitlist Control
Arm Type
No Intervention
Arm Description
Testing at same frequency as Meditative Movement interventional subjects.
Intervention Type
Other
Intervention Name(s)
Meditative Movement taught via DVD
Other Intervention Name(s)
Qigong
Intervention Description
Gentle movement with attention to posture and breathing with emphasis on interoceptive awareness and self regulation.
Primary Outcome Measure Information:
Title
Change in 6 minute walk test
Description
Each participant walks as many ft as possible at a brisk pace. The amount of feet covered in 6 minutes is documented.
Time Frame
Baseline, 4 months
Title
Change in C-reactive protein (CRP)
Description
At each assessment circulating CRP will be monitored via blood collected in form of fingerstick.
Time Frame
Baseline, 4 months
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Systolic and diastolic blood pressure, pre and post 6 minute walk test
Time Frame
Baseline, 4 months
Title
Heart Rate
Description
Heart rate measured pre and post 6 minute walk test
Time Frame
Baseline, 4 months
Title
Oxygen Saturation
Description
O2 saturation measured pre and post 6 minute walk test
Time Frame
Baseline, 4 months
Title
Spirometry: FEV1/FVC
Description
Spirometric measurement of FEV1/FVC administered using EasyOne Spirometer. FEV1/FVC is the ratio of Forced Expiratory Volume (1sec)/FVC (Forced Vital Capacity, (Expiratory))
Time Frame
Baseline, 4 months
Title
Autonomic Function Self Report
Description
Compass-31 administered via individual self-report.
Time Frame
Baseline, 4 months
Title
Zung Anxiety Scale
Description
Zung anxiety questionnaire administered via individual self report.
Time Frame
Baseline, 4 months
Title
Zung Depression Scale
Description
Zung depression questionnaire administered via individual self report.
Time Frame
Baseline, 4 months
Title
Diurnal Salivary Cortisol
Description
4 sputum samples collected from subjects
Time Frame
Baseline, 4 months
Title
Melatonin
Description
Melatonin levels from urine samples
Time Frame
Baseline, 4 months
Title
Nicotine Exposure Autonomic Respiratory Syndrome (NEARS)
Description
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.
Time Frame
Baseline, 4 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Occupation as a flight attendant for at least 5 years No history of significant tobacco use Occupational controls Exclusion Criteria: Inability to give consent History of tobacco habituation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven N Fiering, PhD
Organizational Affiliation
Geisel School of Medicine, Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35237650
Citation
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.
Results Reference
derived
PubMed Identifier
33987172
Citation
Ye 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.
Results Reference
derived
PubMed Identifier
30406067
Citation
Payne 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.
Results Reference
derived
PubMed Identifier
28270757
Citation
Payne 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.
Results Reference
derived
PubMed Identifier
27047398
Citation
Payne 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.
Results Reference
derived
Links:
URL
https://www.frontiersin.org/articles/10.3389/fpsyt.2016.00038/full
Description
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/fps
URL
https://www.frontiersin.org/articles/10.3389/fnhum.2017.00067/full
Description
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/fnhu
URL
https://www.frontiersin.org/articles/10.3389/fpubh.2018.00282/full
Description
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.2018.00282
URL
http://www.bodymindscience.info
Description
Website for Body Mind Science. Investigators are no longer at Dartmouth. Future publication links will be at the BodyMind Science sites.

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Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants

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