Adhesive CapsulitisNCT03467139
Breathing Exercises and Adhesive Capsulitis
A study testing Abdominal breathing exercise in people with Adhesive Capsulitis, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Abdominal breathing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Mar 2017to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who have received an adhesive capsulitis diagnosis,
- Those in the age range 40-65
Who cannot join
- Those who take medicine for pain,
- Those with a primary sleep problem,
- Those with respiratory system disease,
- Those with cognitive problems,
- Non-volunteer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Abdominal Breathing Exercises on Pain, Sleep and Quality of Life in Patients With Adhesive Capsulitis
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.
Read the 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.
- Conditions
- Adhesive Capsulitis
- Being tested
- Abdominal breathing exercise
- Keywords
- Adhesive Capsulitis, Breathing exercises, Pain, Sleep quality, Quality of life
- Medical subject headings
- Bursitis, Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal breathing exerciseOther
Deep Breathing Exercise
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | 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 Receives: Other: Abdominal breathing exercise |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Pain
Visual Analog Scale-Min.score:0 Max.score:10.0 means no pain, 10 means unbearable pain.
Measured: Change from Baseline Pain at 8 weeks
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.
Measured: Change from Baseline Pain at 8 weeks
Sleep Quality
Pittsburgh Sleep Quality Index-Min.score:0 Max.score:21. High total score indicates poor sleep quality.
Measured: Change from Baseline Sleep Quality at 8 weeks
Sleep Quality
Epworth Sleepiness Scale.Min:0-Max:24.0 indicates no sleepiness, and 24 indicates max daytime sleepiness.
Measured: Change from Baseline Sleep Quality at 8 weeks
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.
Measured: Change from Baseline Quality of Life at 8 weeks
Lung Function Test
Lung Function Test
Measured: Change from Baseline Lung Function at 8 weeks
Secondary outcomes (2)
Range of Motion
Universal Goniometer
Measured: Change from Baseline Range of Motion at 8 weeks
Muscle Strength
Manuel Muscle Strength Test
Measured: Change from Baseline Muscle Strength at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start24 Mar 2017
- Primary completion15 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YUSUF ŞİNASİ KIRMACI, Hasan Kalyoncu University
- Investigators
- Hasan Kalyoncu University Health Sciences college, Principal investigator, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467139
- Sponsor's protocol ID
- YusufKirmaci
- Status last verified
- Mar 2018
- First submitted
- 9 Feb 2018
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abdominal Breathing Exercises on Pain, Sleep and Quality of Life in Patients With Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT03467139
- Acronym / sponsor ID
- YusufKirmaci
- Conditions
- Adhesive Capsulitis
- Keywords
- Adhesive Capsulitis, Breathing exercises, Pain, Sleep quality, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 24 Mar 2017 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 15 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Abdominal breathing exerciseHotpack 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 |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Those who have received an adhesive capsulitis diagnosis,
- Those in the age range 40-65
Key exclusion criteria (5 listed)
- Those who take medicine for pain,
- Those with a primary sleep problem,
- Those with respiratory system disease,
- Those with cognitive problems,
- Non-volunteer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal breathing exerciseDeep Breathing Exercise | Other | Study Group |
Primary outcome
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.
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.
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.
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.
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.
Lung Function Test
Time frame: Change from Baseline Lung Function at 8 weeks
Lung Function Test
2 secondary outcomes
Range of Motion
Time frame: Change from Baseline Range of Motion at 8 weeks
Muscle Strength
Time frame: Change from Baseline Muscle Strength at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hasan Kalyoncu University Health Sciences college principal investigator
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal breathing exercise in people with Adhesive Capsulitis, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Change from Baseline Pain at 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2018; AzTrials last refreshed its copy on 30 Oct 2026.