NCT07773194

Brief Summary

This randomized controlled trial evaluated the effects of progressive muscle relaxation and deep breathing exercises on fatigue and sleep quality in patients with chronic obstructive pulmonary disease (COPD). A total of 90 patients were assigned to three groups: a progressive muscle relaxation exercise group, a deep breathing exercise group, and a control group. Participants in the intervention groups were taught their assigned exercises individually and were instructed to practice them daily at home for 8 weeks. The control group received no study intervention during this period. Fatigue and sleep quality were assessed before the intervention and at the end of the 8-week study period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

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 15, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
Last Updated

August 19, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

August 14, 2026

Last Update Submit

August 14, 2026

Conditions

Keywords

COPDprogressive muscle relaxation exercisesdeep breathing exercisesfatiguesleep quality

Outcome Measures

Primary Outcomes (2)

  • Fatigue Level

    Fatigue was assessed using the Chronic Obstructive Pulmonary Disease and Asthma Fatigue Scale. The scale consists of 12 items. Item scores are summed and transformed to a total score ranging from 0 to 100. Higher scores indicate greater levels of fatigue.

    Baseline and 8 weeks after the start of the intervention

  • Sleep Quality

    Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). The global PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A total score of 5 or higher indicates poor sleep quality.

    Baseline and 8 weeks after the start of the intervention

Study Arms (3)

Progressive Muscle Relaxation Exercise Group

EXPERIMENTAL

Participants received individual training on progressive muscle relaxation exercises. The training session lasted approximately 30-40 minutes. Relaxation exercise audio recordings were provided for home practice. Participants were instructed to perform the progressive muscle relaxation exercises every morning at home for 8 weeks. Weekly telephone contact was maintained during the intervention period.

Behavioral: Progressive Muscle Relaxation

Deep Breathing Exercise Group

EXPERIMENTAL

Participants received individual practical training in pursed-lip breathing exercises. The exercises were explained and practiced under guidance in a quiet environment to ensure correct performance. The training session lasted approximately 20-25 minutes. Participants were instructed to perform the breathing exercises every morning at home for 8 weeks.

Behavioral: Deep Breathing Exercise

Control Group

NO INTERVENTION

Participants received no study intervention during the 8-week study period. Outcome assessments were performed at baseline and at the end of 8 weeks.

Interventions

Participants received individual training on progressive muscle relaxation exercises. The training lasted approximately 30-40 minutes. Relaxation exercise audio recordings were provided to support home practice. Participants were instructed to perform the progressive muscle relaxation exercises every morning at home for 8 weeks. Weekly telephone contact was maintained during the intervention period.

Progressive Muscle Relaxation Exercise Group

Participants received individual practical training in pursed-lip breathing exercises. The technique was explained verbally and practiced under guidance in a quiet environment to ensure correct performance. The training lasted approximately 20-25 minutes. Participants were instructed to perform the breathing exercises every morning at home for 8 weeks.

Deep Breathing Exercise Group

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with chronic obstructive pulmonary disease (COPD) according to GOLD criteria at least 6 months before enrollment.
  • Able to communicate verbally. No severe hearing or visual impairment. No serious medical condition or serious complication related to COPD.

You may not qualify if:

  • Presence of a perceptual disorder or psychiatric condition that impairs communication.
  • Presence of a serious complication related to COPD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gül DURAL

Elâzığ, 23020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveFatigueSleep Initiation and Maintenance Disorders

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 14, 2026

First Posted

August 19, 2026

Study Start

February 15, 2025

Primary Completion

January 15, 2026

Study Completion

January 15, 2026

Last Updated

August 19, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because data sharing was not included in the original study protocol or informed consent process.

Locations