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Breathing Exercises and Adhesive Capsulitis

Primary Purpose

Adhesive Capsulitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Abdominal breathing exercise
Sponsored by
Hasan Kalyoncu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Adhesive Capsulitis, Breathing exercises, Pain, Sleep quality, Quality of life

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hasan Kalyoncu Unıversity

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study Group

Control Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Pain
Visual Analog Scale-Min.score:0 Max.score:10.0 means no pain, 10 means unbearable pain.
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.
Sleep Quality
Pittsburgh Sleep Quality Index-Min.score:0 Max.score:21. High total score indicates poor sleep quality.
Sleep Quality
Epworth Sleepiness Scale.Min:0-Max:24.0 indicates no sleepiness, and 24 indicates max daytime sleepiness.
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.
Lung Function Test
Lung Function Test

Secondary Outcome Measures

Range of Motion
Universal Goniometer
Muscle Strength
Manuel Muscle Strength Test

Full Information

First Posted
February 9, 2018
Last Updated
March 15, 2018
Sponsor
Hasan Kalyoncu University
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1. Study Identification

Unique Protocol Identification Number
NCT03467139
Brief Title
Breathing Exercises and Adhesive Capsulitis
Official Title
The Effect of Abdominal Breathing Exercises on Pain, Sleep and Quality of Life in Patients With Adhesive Capsulitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 24, 2017 (Actual)
Primary Completion Date
June 15, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
Adhesive Capsulitis, Breathing exercises, Pain, Sleep quality, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Abdominal breathing exercise
Intervention Description
Deep Breathing Exercise
Primary Outcome Measure Information:
Title
Pain
Description
Visual Analog Scale-Min.score:0 Max.score:10.0 means no pain, 10 means unbearable pain.
Time Frame
Change from Baseline Pain at 8 weeks
Title
Pain
Description
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.
Time Frame
Change from Baseline Pain at 8 weeks
Title
Sleep Quality
Description
Pittsburgh Sleep Quality Index-Min.score:0 Max.score:21. High total score indicates poor sleep quality.
Time Frame
Change from Baseline Sleep Quality at 8 weeks
Title
Sleep Quality
Description
Epworth Sleepiness Scale.Min:0-Max:24.0 indicates no sleepiness, and 24 indicates max daytime sleepiness.
Time Frame
Change from Baseline Sleep Quality at 8 weeks
Title
Quality of Life
Description
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.
Time Frame
Change from Baseline Quality of Life at 8 weeks
Title
Lung Function Test
Description
Lung Function Test
Time Frame
Change from Baseline Lung Function at 8 weeks
Secondary Outcome Measure Information:
Title
Range of Motion
Description
Universal Goniometer
Time Frame
Change from Baseline Range of Motion at 8 weeks
Title
Muscle Strength
Description
Manuel Muscle Strength Test
Time Frame
Change from Baseline Muscle Strength at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasan Kalyoncu University Health Sciences college
Organizational Affiliation
Hasan Kalyoncu University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasan Kalyoncu Unıversity
City
Gaziantep
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Breathing Exercises and Adhesive Capsulitis

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