Clinical trial NCT05846204: Progressive Muscle Relaxation and Deep Breathing Exercises
Official title: The Effect of Progressive Muscle Relaxation and Deep Breathing Exercises Training on Dyspnea, Fatigue and, Quality of Sleep in Patients With COPD: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Progressive Muscle Relaxation
Deep Breath
COPD
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The population of the study was composed of 186 patients whose cells were assigned to Atatürk University Hospital Educational Diseases Polyclinic between April and June 2023, and whose cells were found to have COPD according to the Chronic Obstructive Pulmonary Disease Initiative by the physician. A total of 140 patients approved the inclusion criteria and agreed to participate in the study. Priori power analysis was performed for sampling determination. In the power analysis, Cohen's medium effect size reference method was chosen. As a result of the power analysis, it was determined that it should be done with a total of 90 patients, 30 patients in each group, two experimental groups and the control group (α=0.05, power=0.8, and effect expectation=0.65). In case of data loss, this number plus approximately 20% reserve allocation included 36 patients in each group. However, the study was completed with a total of 96 patients, including PMR(n=31), DB(n=32) and 33 control subjects.

Detailed description: The PMR exercise, which includes the systematic relaxation of the main muscle groups of the body aimed at physical and psychological relaxation, was applied twice a day, every weekday, for eight weeks. PMR exercises and these exercises were given to the patients individually.

The training for the implementation of the exercises was given by face-to-face interview method. During the training process, "Muscle Relaxation Exercises Practice Guide" and "Relaxation Exercises Audio Recordings", which were prepared by the researcher and included relaxation exercises, were used.

Deep Breath exercises training was given to the patients in this group individually by face-to-face interview. During the application, the importance of deep and comfortable breathing was explained and correct breathing technique was taught. Informing and application training took an average of 20-25 minutes for each patient. The patients were told to do the 10-minute application at home 3 times a day for 8 weeks. They were called once a week and asked whether they continued the practice and whether they had any difficulties during the exercises.

Eligibility criteria: Inclusion Criteria:

* Not having any physical problems
* Conscious
* Fully oriented
* Not have an acute exacerbation attack in the past month

Exclusion Criteria:

* Having a hearing problem,
* Inability to practice relaxation exercises regularly,
* Wanting to leave the study
* Neurological diseases,
* Those with comorbidities such as acute myocardial infarction or cancer,

Primary outcomes:
measure: Chronic Obstructive Pulmonary Disease and Asthma Fatigue Scale
timeFrame: two week
measure: Dyspnea-12 Scale
timeFrame: Two week
measure: Pittsburgh Sleep Quality Index
timeFrame: Two week
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk Unıversity
state: Yakutiye
Study officials:
affiliation: Ataturk University
name: Nihan Türkoğlu, Assist.Prof.
role: STUDY_CHAIR
References: