NCT06022627

Brief Summary

The aim of the study In this study, pranayama yoga practices are the sub-dimensions of respiratory parameters, symptom and disease affection level, psychosocial adjustment and psychosocial adjustment in individuals with COPD. It was planned in a randomized controlled manner to examine the effects of healthcare compliance, professional environment, family environment, sexual relations, extended family relationships, social environment and psychological pressure. Pranayama yoga practices are aimed to reduce the frequency of symptoms and the level of disease exposure in individuals with COPD. Pranayama yoga practices are aimed to increase psychosocial adjustment in individuals with COPD. Pranayama yoga practices aim to increase compliance with health care, occupational, social and family environment, sexual and extended family relationships, and psychological pressure, which are the sub-dimensions of psychosocial adjustment in individuals with COPD. It is observed that all the yoga practices performed have improved the pulmonary functions of individuals with COPD, decrease the severity of symptoms, relieve inflammation, and increase muscle strength and physical performance. It was concluded that because of yoga increases awareness in patients, patients significantly reduce their level of depression and anxiety and adapt to social life. Yoga improves patients' quality of life by alleviating symptoms and increasing self-awareness. pranayama yoga practices are safe, home-applied, effective, cost-effective, complementary to drug therapy and can be performed during pulmonary rehabilitation for individuals with COPD (1-2) . The results of this study are important in guiding caregivers and healthcare professionals during the holistic care of COPD individuals and in pulmonary rehabilitation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 23, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
Last Updated

September 5, 2023

Status Verified

September 1, 2023

Enrollment Period

22 days

First QC Date

July 23, 2023

Last Update Submit

September 1, 2023

Conditions

Keywords

Pranayama YogaCOPDSemptomsFatiguePulmonary functions

Outcome Measures

Primary Outcomes (1)

  • COPD Assesment Test (CAT)

    Assesment Test

    21 days

Secondary Outcomes (2)

  • SPIROMETER

    21 days

  • Asthma Fatigue Scale (CAFS)

    21 days

Study Arms (2)

Pranayam Yoga Group

EXPERIMENTAL

It was planned to use a simple random sampling method among individuals who met the research inclusion criteria and agreed to participate voluntarily in the study. During randomization; Patients in the study and control groups will be determined using the random.org site. While the routine treatment of the patients in the study group continues, 20 minutes of pranayama yoga training will be given by the yoga instructor to the patient and his relatives, and it is planned that the patient will practice pranayama yoga, which is taught for 20 minutes every day for 21 days. Patients or their relatives will be called every morning by phone or video communication will be made online and pranayama yoga will be provided. In addition, a training booklet describing pranayama yoga exercises in detail, a training video and a 21-day checklist of doing yoga will be given to the patients. function test will be done and checklists will be taken back from patients.

Behavioral: Pranayama Yoga

Non-Pranayama Yoga Group

NO INTERVENTION

The routine treatment of the control group will continue and any intervention will not be applied. After the data collection process of the study is completed, paranayama yoga training will be given to the patients in the control group and they will be advised to do it regularly for at least 21 days.

Interventions

Pranayama YogaBEHAVIORAL

Doing practice of paranayam yoga which including breathing exercises yoga-life energy

Pranayam Yoga Group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 40-65
  • To have been diagnosed with Stage I or Stage II COPD for at least six months
  • Absence of any communication problem \[decreased hearing, visual impairment, inability to understand/speak Turkish\] that would prevent participation in the research,
  • Least literate
  • Do not have any mental or physical disability that would prevent them from practicing Pranayama Yoga.
  • Not having done pranayama yoga before
  • No tracheostomy
  • Telephone communication is possible.
  • The patients who accepted to participate in the study voluntarily constitute the sample of the study.

You may not qualify if:

  • Being diagnosed with Stage III and Stage IV COPD,
  • Patients under the age of 40 and not over the age of 65
  • Individuals who are bored during the interview and give up on the interview will not be included in the study and their data will not be used.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University

Istanbul, Ataşehir, 34758, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic ObstructiveBronchitis, ChronicFatigue

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: 66 individuals with COPD included by randomization were divided into two groups as 33 (16 Stage I and 17 Stage II) study group and 33 (16 Stage I and 17 Stage II) control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2023

First Posted

September 5, 2023

Study Start

August 25, 2023

Primary Completion

September 16, 2023

Study Completion

September 20, 2023

Last Updated

September 5, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations