Clinical trial NCT05266352: Investigation of the Effect of Exercise Training on Psychosocial Outcomes in Rotator Cuff Tears
Official title: Investigation of the Effect of Exercise Training on Psychosocial Outcomes in Rotator Cuff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Pain, Shoulder
Psychological
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to determine the psychosocial effects of exercise training in patients with rotator cuff tears.

Detailed description: This study aimed to determine the psychosocial effects of exercise training in patients with rotator cuff tears. Fifty voluntary patients with partial rotator cuff tear will be randomized into two groups: Supervised exercise group (SE) and home exercise (HE) group, for a standardized 8 weeks exercise program. The primary outcome is the Constant-Murley Score (CMS). The secondary outcomes are the Visual Analogue Scale (VAS), active range of motion (AROM), Pain Catastrophizing Scale (PCS), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSI), Short Form-12 (SF-12), and Global Rating of Change (GRC). Outcome measures will be performed at baseline and at the end of 8-week intervention.

Eligibility criteria: Inclusion Criteria: Forty years of age or older patients that have been diagnosed for a partial rotator cuff tear that is unrelated to trauma by a specialist orthopedist with MRI and physical examination and no other shoulder problems on the diagnosed shoulder will be included into this study.

Exclusion Criteria: Patients diagnosed with full-thickness or massive rotator cuff tear, patients who undergone previous surgery, patients diagnosed with frozen shoulder or glenohumeral instability, and athletic patients younger than 40 years of age with symptoms of acute RC tear will not be included into this study.

Primary outcomes:
measure: Constant-Murley Score
timeFrame: Baseline
Secondary outcomes:
measure: Constant-Murley Score
timeFrame: At the end of 8-week intervention
measure: Visual Analogue Scale (VAS)
timeFrame: Baseline
measure: Visual Analogue Scale (VAS)
timeFrame: At the end of 8-week intervention
measure: Active Range of Motion (AROM) Assessment
timeFrame: Baseline
measure: Active Range of Motion (AROM) Assessment
timeFrame: At the end of 8-week intervention
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline
measure: Pain Catastrophizing Scale (PCS)
timeFrame: At the end of the 8-week intervention
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: At the end of the 8-week intervention
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At the end of the 8-week intervention
measure: Short Form-12 (SF-12)
timeFrame: Baseline
measure: Short Form-12 (SF-12)
timeFrame: At the end of the 8-week intervention
measure: Global Rating of Change (GRC)
timeFrame: At the end of the 8-week intervention
measure: Exercise Dairy
timeFrame: At the end of the 8-week intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Bakırkoy
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Tansu Birinci, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: