NCT05266352

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration 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

First Submitted

Initial submission to the registry

February 28, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

February 28, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2024

Completed
Last Updated

October 8, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

February 28, 2022

Last Update Submit

October 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Constant-Murley Score

    The functional level will be assessed by the Constant Murley Score, which is a 100-point scale consisting of 15 points for pain, 20 points for daily activities, 40 points for pain-free range of motion, and 25 points for strength. High scores are positively correlated with the increased functional level. While pain and activities of daily living are evaluated by the patient, range of motion and strength are evaluated by the clinician.

    Baseline

Secondary Outcomes (15)

  • Constant-Murley Score

    At the end of 8-week intervention

  • Visual Analogue Scale (VAS)

    Baseline

  • Visual Analogue Scale (VAS)

    At the end of 8-week intervention

  • Active Range of Motion (AROM) Assessment

    Baseline

  • Active Range of Motion (AROM) Assessment

    At the end of 8-week intervention

  • +10 more secondary outcomes

Study Arms (2)

Supervised exercise group

EXPERIMENTAL

The group received the supervised exercise program

Other: Supervised exercise program

Home exercise group

ACTIVE COMPARATOR

The group received the home exercise program

Diagnostic Test: Home exercise program

Interventions

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.

Supervised exercise group
Home exercise programDIAGNOSTIC_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.

Home exercise group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Bakırkoy, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff InjuriesShoulder Pain

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tansu Birinci, PT, PhD

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 4, 2022

Study Start

February 28, 2022

Primary Completion

February 28, 2023

Study Completion

February 14, 2024

Last Updated

October 8, 2024

Record last verified: 2024-03

Locations