- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03467139
Breathing Exercises and Adhesive Capsulitis
The Effect of Abdominal Breathing Exercises on Pain, Sleep and Quality of Life in Patients With Adhesive Capsulitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Gaziantep, Turkey
- Hasan Kalyoncu Unıversity
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study 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 in 10 sets of 3 sets (flexion, abduction, internal and external rotation) to increase joint range of motion by physiotherapist.
Then, abdominal breathing exercise training was given 3 times a week as 30 sets of 3 sets a week and the patients were treated for 8 weeks
|
Deep Breathing Exercise
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: Change from Baseline Pain at 8 weeks
|
Visual Analog Scale-Min.score:0
Max.score:10.0
means no pain, 10 means unbearable pain.
|
Change from Baseline Pain at 8 weeks
|
Pain
Time Frame: Change from Baseline Pain at 8 weeks
|
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
|
Sleep Quality
Time Frame: Change from Baseline Sleep Quality at 8 weeks
|
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
|
Sleep Quality
Time Frame: Change from Baseline Sleep Quality at 8 weeks
|
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
|
Quality of Life
Time Frame: Change from Baseline Quality of Life at 8 weeks
|
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.
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Change from Baseline Quality of Life at 8 weeks
|
Lung Function Test
Time Frame: Change from Baseline Lung Function at 8 weeks
|
Lung Function Test
|
Change from Baseline Lung Function at 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of Motion
Time Frame: Change from Baseline Range of Motion at 8 weeks
|
Universal Goniometer
|
Change from Baseline Range of Motion at 8 weeks
|
Muscle Strength
Time Frame: Change from Baseline Muscle Strength at 8 weeks
|
Manuel Muscle Strength Test
|
Change from Baseline Muscle Strength at 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hasan Kalyoncu University Health Sciences college, Hasan Kalyoncu University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YusufKirmaci
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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