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CompletedNCT05846204Updated Jul 19, 2023

Progressive Muscle Relaxation and Deep Breathing Exercises

An interventional study of Progressive Muscle Relaxation and Deep Breathing Exercise Group-DBE in Progressive Muscle Relaxation, Deep Breath and COPD, sponsored by Ataturk University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-19.

Sponsored by Ataturk University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Progressive Muscle Relaxation
  • Deep Breath
  • COPD
03

In context

Lead sponsor

Ataturk University is the lead sponsor of 442 studies on the registry; 121 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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,
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
96 participants (actual)

Study arms

  • Experimental
    PMR Group

    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 training on the application of these exercises were given to the patients individually 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. Voice recordings were uploaded to each patient's mobile phone so that they could continue the application at home. The steps of the relaxation exercises were explained to the patient by the researcher and he was shown exactly how to do the exercises.

    Behavioral: Progressive Muscle Relaxation

  • Experimental
    Deep Breath Group

    WB 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.

    Behavioral: Deep Breathing Exercise Group-DBE

  • No intervention
    Control

    No intervention will be applied to the control group.

Interventions

  • BehavioralProgressive Muscle Relaxation

    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. DB 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.

  • BehavioralDeep Breathing Exercise Group-DBE

    Breathing exercise is an exercise to improve breathing and functional performance. deep breathing exercise; It is a nursing intervention that helps to increase the function of respiratory muscles and improve ventilation and oxygenation.

06

What researchers measure

Primary outcomes

  1. Chronic Obstructive Pulmonary Disease and Asthma Fatigue Scale

    The COPD and Asthma Fatigue Scale (CAFS) was developed by Revicki et al. In the scale consisting of a total of 12 questions, the items of the questions are graded in a Likert type. The total raw score is obtained by summing all item scores, and the raw scores are converted to a total scale score between 0 and 100 points. The increase in the scale score indicates the increase in the fatigue level of the person.

    Time frame: two week

  2. Dyspnea-12 Scale

    The scale developed by Yorke et al. consists of 12 items measuring the severity of dyspnea. It consists of 4-point Likert type options. The highest score that can be obtained from the physical sub-dimension of the scale is 21, and the highest score that can be obtained from the emotional sub-dimension is 15. The lowest score of the scale is 0, and the highest score is 36. An increase in the score obtained from the scale indicates an increase in the severity of dyspnea.

    Time frame: Two week

  3. Pittsburgh Sleep Quality Index

    Designed by PSQI, Buysee et al. PSQI specifically measures subjective sleep quality over a one-month period. The PSQI includes 19 items on seven subscales: subjective sleep quality, sleep duration, sleep disturbance, sleep delay, sleep efficiency, use of sleep medication, and daytime dysfunction. Items are scored on a 4-point Likert scale from 0 to 3 points. Scores of the subscales are added to an overall PSQI score. The total score of the questionnaire ranges from 1 to 21 points, where scores higher than 5 indicate poor sleep quality and scores lower than 5 indicate no sleep disturbance.

    Time frame: Two week

07

Study locations

1 site
  • Ataturk Unıversity
    Erzurum, Yakutiye 25240, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05846204
Lead sponsor
Ataturk University
Responsible party
NİHAN TÜRKOĞLU (Assist Prof., Ataturk University) — Principal investigator
First posted
May 6, 2023
Start date
Apr 15, 2023
Primary completion
May 15, 2023
Completion
Jul 15, 2023
Last update
Jul 19, 2023

Study contacts

Nihan Türkoğlu, Assist.Prof.
study chair · Ataturk University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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