NCT03467139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2017

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
Last Updated

March 16, 2018

Status Verified

March 1, 2018

Enrollment Period

3 months

First QC Date

February 9, 2018

Last Update Submit

March 15, 2018

Conditions

Keywords

Adhesive CapsulitisBreathing exercisesPainSleep qualityQuality of life

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • Lung Function Test

    Lung Function Test

    Change from Baseline Lung Function at 8 weeks

Secondary Outcomes (2)

  • Range of Motion

    Change from Baseline Range of Motion at 8 weeks

  • Muscle Strength

    Change from Baseline Muscle Strength at 8 weeks

Study Arms (2)

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

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.

Interventions

Deep Breathing Exercise

Study Group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those who have received an adhesive capsulitis diagnosis,
  • Those in the age range 40-65

You may not qualify if:

  • Those who take medicine for pain,
  • Those with a primary sleep problem,
  • Those with respiratory system disease,
  • Those with cognitive problems,
  • Non-volunteer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu Unıversity

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

BursitisPainSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Hasan Kalyoncu University Health Sciences college

    Hasan Kalyoncu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Yusuf Şinasi Kırmacı,Principal Investigator,Physical Therapist

Study Record Dates

First Submitted

February 9, 2018

First Posted

March 15, 2018

Study Start

March 24, 2017

Primary Completion

June 15, 2017

Study Completion

June 30, 2017

Last Updated

March 16, 2018

Record last verified: 2018-03

Locations