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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03467139
Other study ID # YusufKirmaci
Secondary ID
Status Completed
Phase N/A
First received February 9, 2018
Last updated March 15, 2018
Start date March 24, 2017
Est. completion date June 30, 2017

Study information

Verified date March 2018
Source Hasan Kalyoncu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study was to determine the effects of abdominal breathing exercises on pain, sleep quality and quality of life with adhesive capsulitis patients. The 41 adhesive capsulitis patients, 29 women and 12 men aged between 40-65 years, had divided into two groups by simple random sampling. In the study group, abdominal breathing exercise training was applied to routine physiotherapy program, in the control group routine physiotherapy program was applied for 8 weeks. Individuals were assessed for lung function test, range of motion, pain, sleep quality and quality of life. First assesment were performed at the beginning of treatment, 2nd assesment were performed at the end of 8 th week.


Description:

Pain in the early stages of adhesive capsulitis leads to many symptoms such as sleeping problems. Breathing exercises also began to take place among the applications towards pain. Abdominal respiration is considered the easiest method to reveal relaxation response. Slow breathing increases parasympathetic activity in the body and reduces sympathetic activity. This is the first and fundamental step of real healing. The reduction of pro-inflammatory markers with respiratory exercises suggests that respiratory exercises are effective in inflammation.

On study group; Hotpack was applied for 15 minutes and TENS was applied for 15 minutes and ultrasonics for 5 minutes. Then, scapular mobilization and passive stretching exercises were applied in 10 sets of 3 sets (flexion, abduction, internal and external rotation) to increase joint range of motion by physiotherapist. Then abdominal respiratory exercise training was given 3 times a week as 30 sets of 3 times a week and patients were treated for 8 weeks.

For the control group; Hotpack was applied for 15 min and TENS was applied for 15 min and ultrasonics for 5 min. Then scapular mobilization and passive stretching exercises were applied for 8 weeks in 10 sets of 3 sets (flexion, abduction, internal and external rotation) to increase joint range of motion by physiotherapist.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date June 30, 2017
Est. primary completion date June 15, 2017
Accepts healthy volunteers No
Gender All
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria:

- Those who have received an adhesive capsulitis diagnosis,

- Those in the age range 40-65

Exclusion Criteria:

- Those who take medicine for pain,

- Those with a primary sleep problem,

- Those with respiratory system disease,

- Those with cognitive problems,

- Non-volunteer

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Abdominal breathing exercise
Deep Breathing Exercise

Locations

Country Name City State
Turkey Hasan Kalyoncu University Gaziantep

Sponsors (1)

Lead Sponsor Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Visual Analog Scale-Min.score:0 Max.score:10.0 means no pain, 10 means unbearable pain. Change from Baseline Pain at 8 weeks
Primary Pain Shoulder Pain and Disability Index: It consists of 2 subtitles.First subtitle is pain, has 5 items. first subtitle: Min:0-Max:100. 0 means no pain in functional activities, and 100 means irresistible pain. Second subtitle is disability,has 8 items. Min. score is 0, Max score is 100. 0 means no disability in functional activities, 100 means disabile in functional activities. Total score changes 0-100. 0 shows best score, 100 shows worst score. Change from Baseline Pain at 8 weeks
Primary Sleep Quality Pittsburgh Sleep Quality Index-Min.score:0 Max.score:21. High total score indicates poor sleep quality. Change from Baseline Sleep Quality at 8 weeks
Primary Sleep Quality Epworth Sleepiness Scale.Min:0-Max:24.0 indicates no sleepiness, and 24 indicates max daytime sleepiness. Change from Baseline Sleep Quality at 8 weeks
Primary Quality of Life SF-36:It consists of 36 items in total. It consists of 8 subtitles. (3 items), Energy (4 items), Mental Health (5 items), Social Function (2 items), Pain (2 items), General (10 items), Physical Role Strength Health Scale (8 items). The lower scales measure the health between 0 and 100, and 0 refers to the poor health status and 100 to the good health status. Change from Baseline Quality of Life at 8 weeks
Primary Lung Function Test Lung Function Test Change from Baseline Lung Function at 8 weeks
Secondary Range of Motion Universal Goniometer Change from Baseline Range of Motion at 8 weeks
Secondary Muscle Strength Manuel Muscle Strength Test Change from Baseline Muscle Strength at 8 weeks
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