NCT04623762

Brief Summary

Although there are a limited number of studies in the literature investigating the effect of yoga on dyspnea, quality of life and respiratory functions of chronic respiratory patients There is no study examining the effect of yoga on sleep and fatigue of chronic respiratory patients. Therefore, this study was conducted to determine the effect of yoga on dyspnea, sleep, and fatigue applied to chronic respiratory patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

14 days

First QC Date

October 29, 2020

Last Update Submit

November 9, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Chronic Obstructive Pulmonary Disease and Asthma Fatigue Scale

    Revicki et al. (2010) to determine the effect of COPD and asthma on fatigue. Cronbach's alpha value of the scale was found to be 0.95. The scale, which consists of 12 items, is a five-point Likert type, and the minimum total score that can be obtained from the scale is 12 and the maximum total score is 60. The higher the score obtained from the scale indicates that the fatigue level of the person is high. Turkey on the scale of the Turkish validity and reliability study of Arslan and by Öztunç (2013) was determined to be conducted and Cronbach's alpha values for the reliability coefficient of 0.92.

    Change from Baseline Fatigue at 2 months

Secondary Outcomes (1)

  • Asthma and COPD Sleep Scale (CASIS)

    Change from Baseline Sleep at 2 months

Other Outcomes (2)

  • Medical Research Board Dyspnea Scale (MRC):

    Change from Baseline MRC at 2 months

  • Pulmonary Functions Monitoring Form

    Change from Baseline Pulmonary Functions at 2 months

Study Arms (2)

Control group

NO INTERVENTION

yoga was not done

Experimental group

EXPERIMENTAL

yoga was done

Other: Yoga

Interventions

YogaOTHER

yoga application

Experimental group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18-55 and diagnosed with asthma and COPD for at least six months,
  • Do not have any disease that causes insomnia and do not use sleeping pills
  • Has the ability to use the internet actively, download the ZOOM program to the phone or computer and participate in the application.
  • Have not participated in a similar regular exercise program in the last 6 months,
  • Do not have any respiratory system disease other than asthma and COPDY,
  • Not in exacerbation period,
  • Do not have a physical illness or cognitive deficiency and a psychiatric disease that prevents understanding of the education given,
  • Patients who were literate and volunteered to participate in the study were included in the study.

You may not qualify if:

  • In the period of exacerbation Have participated in a similar regular exercise program in the last 6 months, Those who cannot download the ZOOM program and participate in the application

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fırat university

Erzurum, Center, 25240, Turkey (Türkiye)

Location

Sabahattin Zaim University

Istanbul, Center, 25240, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Gülcan Bahçecioğlu Turan

    Fırat Universty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSISTANT PROFESSOR

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 10, 2020

Study Start

May 1, 2020

Primary Completion

May 15, 2020

Study Completion

July 28, 2020

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations