NCT02612389

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 23, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

5.3 years

First QC Date

November 19, 2015

Last Update Submit

August 14, 2020

Conditions

Keywords

COPDQigongANSMeditative MovementFlight AttendantsSecondhand SmokeNicotineBlood Pressure6 minute walk test

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline, 4 months

  • Change in C-reactive protein (CRP)

    At each assessment circulating CRP will be monitored via blood collected in form of fingerstick.

    Baseline, 4 months

Secondary Outcomes (10)

  • Blood Pressure

    Baseline, 4 months

  • Heart Rate

    Baseline, 4 months

  • Oxygen Saturation

    Baseline, 4 months

  • Spirometry: FEV1/FVC

    Baseline, 4 months

  • Autonomic Function Self Report

    Baseline, 4 months

  • +5 more secondary outcomes

Study Arms (2)

MM Intervention taught via DVD

EXPERIMENTAL

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

Other: Meditative Movement taught via DVD

MM Intervention Waitlist Control

NO INTERVENTION

Testing at same frequency as Meditative Movement interventional subjects.

Interventions

Gentle movement with attention to posture and breathing with emphasis on interoceptive awareness and self regulation.

Also known as: Qigong
MM Intervention taught via DVD

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Inability to give consent
  • History of tobacco habituation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Lung DiseasesPrimary DysautonomiasPulmonary Disease, Chronic Obstructive

Interventions

Qigong

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesAutonomic Nervous System DiseasesNervous System DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Breathing ExercisesMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Steven N Fiering, PhD

    Geisel School of Medicine, Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

November 19, 2015

First Posted

November 23, 2015

Study Start

March 1, 2015

Primary Completion

June 17, 2020

Study Completion

July 17, 2020

Last Updated

August 18, 2020

Record last verified: 2020-08

Locations