NCT05397275

Brief Summary

Aim: This study was conducted to determine the effect of progressive muscle relaxation and breathing exercise on sleep quality and exercise self-efficacy in chronic obstructive pulmonary patients. Methods: This study was conducted as a randomized controlled experimental study. The study was conducted with 64 chronic obstructive pulmonary patients, where 36 of them were in the intervention group and 34 in the control group. Data of the study were collected using the descriptive information form, the Pittsburgh Sleep Quality Index, and the Exercise Self-Regulatory Efficacy Scale (Ex-SRES) for patients with COPD. Results: When the total scores pertaining to the sleep quality index and exercise self-efficacy of the individuals in the intervention and control groups were compared, it was found that there were statistically significant differences in the intervention group compared to the control group (p \< 0.05). Keywords: Exercise Self-Regulatory Efficacy, sleep quality in patients with COPD, PGE along with breathing exercises, pulmonary rehabilitation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

May 20, 2022

Last Update Submit

May 25, 2022

Conditions

Keywords

Exercise Self-Regulatory Efficacy,sleep qualityPGE with breathing exercisespulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

  • progressive muscle relaxation exercises changes sleep quality and exercise self-efficacy.

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index as an pre- test and 4 weeks later as a post-test test.

    1 mounth

Secondary Outcomes (1)

  • progressive muscle relaxation exercises with breathing exercise changes sleep quality and exercise self-efficacy.

    1 mounth

Study Arms (2)

experimental group

EXPERIMENTAL

progressive muscle relaxation exercises + breathing exercise

Other: progressive muscle relaxation+breathe exercises

control group

EXPERIMENTAL

only breathing exercise

Other: breathe exercises

Interventions

progressive muscle relaxation+breathe exercises

experimental group

breathe exercises

control group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • were to be 18 years of age or older
  • not using sleeping pills
  • verbally stating that they have moderate and severe sleep disorders.

You may not qualify if:

  • having any lung disease other than COPD
  • having cardiological problems (heart failure, uncontrollable hypertension, history of angina and myocardial infarction, heart valve problems), psychotic disorder,
  • inability to communicate verbally and having hearing problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aksaray University

Aksaray, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

May 20, 2022

First Posted

May 31, 2022

Study Start

February 1, 2021

Primary Completion

July 1, 2021

Study Completion

October 1, 2021

Last Updated

May 31, 2022

Record last verified: 2022-05

Locations