- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07043959
- Original Trial
Comparative Effects of Isometrics Versus Range of Motion Exercises on Pain, Mobility and Functional Independence in Post-Mastectomy Patients
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Faisalābad, Pakistan
- The University of Faisalabad
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women between the ages of 45 and 65
- Underwent a one-sided mastectomy
- No history of shoulder injuries
- Able to understand instructions and provide informed consent
Exclusion Criteria:
- Experiencing severe pain
- Diagnosed with advanced lymph edema
- Physically unable to engage in exercises
- Medically unstable
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Isometrics Exercise Group A
Group A received a hot pack for 10-15 minutes and performed deep breathing exercises for 3-4 repetitions.
Patients were instructed in diaphragmatic breathing, where they inhaled deeply, held their breath for 2-3 seconds, and then exhaled.
Following this, isometric exercises were performed, consisting of 2 sets of each exercise with 5-7 repetitions per set, done three times per week for a total duration of 8 weeks.
|
Shoulder Squeeze: The therapist instructed the patient to lift their arms to shoulder height while keeping the elbows bent, then move the arms backward until the shoulder blades come together. Arm Lift to Front and Side: The therapist instructed the patient to raise their arm forward and upward while applying gentle resistance for 2-3 seconds to facilitate front arm elevation. Then, the patient was guided to lift the arm sideways, with slight resistance applied for 2-3 seconds to assist in side-arm elevation. |
|
Active Comparator: Range of Motion Exerccise Group B
Group B received a hot pack for 10-15 minutes and performed deep breathing exercises for 3-4 repetitions.
Patients were guided in diaphragmatic breathing, where they inhaled deeply, held their breath for 2-3 seconds, and then exhaled.
Afterward, they performed Range of Motion (ROM) exercises, consisting of 2 sets of each exercise with 5-7 repetitions per set, conducted three times per week over a period of 8 weeks.
|
Wall Climb for Flexion: The therapist instructed the patient to move their fingers upward along the wall until they reach their limit, then repeat the movement. Arm across Chest for Adduction and Internal Rotation: The therapist instructed the patient to move the affected arm toward the unaffected arm and shoulder. Wand Exercise for Flexion and Abduction: The patient was instructed to hold a wand with both hands and move it forward and sideways toward the affected side |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder Pain
Time Frame: Eight Weeks
|
Numeric Pain Rating Scale (NPRS) with decreasing values indicates improved patient condition and reduced pain intensity.
|
Eight Weeks
|
|
Shoulder ROM
Time Frame: Eight Weeks
|
Goniometer with increasing ROM indicates improved patient condition and joint movements.
|
Eight Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder Functional Independence
Time Frame: Eight Weeks
|
Upper Extremity Functional Scale determines the level of function of participant where higher score indicates improved upper extremity function and reduced functional impairment.
|
Eight Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr Izza Ayub; PT, Department of Rehabilitaion Sciences, The University of Faisalabad
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TUF/PB/40/1033/40
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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