Investigation of the Effect of Exercise Training on Psychosocial Outcomes in Rotator Cuff Tears

NCT ID: NCT05266352

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2024-02-14

Brief Summary

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

Detailed Description

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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.

Conditions

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Rotator Cuff Tears Pain, Shoulder Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Supervised exercise group

The group received the supervised exercise program

Group Type EXPERIMENTAL

Supervised exercise program

Intervention Type OTHER

A structured program consisting of range of motion, postural control, scapulothoracic strengthening, glenohumeral strengthening and dynamic stabilization exercises used in conservative treatment of rotator cuff tears will be performed for 8 weeks.

Patients will do the exercises under control of the physiotherapist in the clinic.

Home exercise group

The group received the home exercise program

Group Type ACTIVE_COMPARATOR

Home exercise program

Intervention Type DIAGNOSTIC_TEST

A structured program consisting of range of motion, postural control, scapulothoracic strengthening, glenohumeral strengthening and dynamic stabilization exercises used in conservative treatment of rotator cuff tears will be performed for 8 weeks.

Patients will do the exercises at home. Patients will visit the clinic every 2 weeks and progression of exercise program will be made.

Interventions

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Supervised exercise program

A structured program consisting of range of motion, postural control, scapulothoracic strengthening, glenohumeral strengthening and dynamic stabilization exercises used in conservative treatment of rotator cuff tears will be performed for 8 weeks.

Patients will do the exercises under control of the physiotherapist in the clinic.

Intervention Type OTHER

Home exercise program

A structured program consisting of range of motion, postural control, scapulothoracic strengthening, glenohumeral strengthening and dynamic stabilization exercises used in conservative treatment of rotator cuff tears will be performed for 8 weeks.

Patients will do the exercises at home. Patients will visit the clinic every 2 weeks and progression of exercise program will be made.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Tansu Birinci

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tansu Birinci, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Locations

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Istanbul University-Cerrahpasa

Istanbul, Bakırkoy, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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108

Identifier Type: -

Identifier Source: org_study_id

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