NCT07043959

Brief Summary

The aim of study was to investigate the comparative effectiveness of Isometrics versus Range of Motion (ROM) Exercises on Pain, Mobility and Functional Independence post-mastectomy. A randomized clinical trial was conducted, in which 30 participants were randomly assigned to 2 parallel groups. One group received Isometric Exercises, while the other received Range of Motion Exercises. Outcome measures included pain, range of motion and functional independence. Treatments were administered 3 times per week with 2 sets of each exercise with 5-7 repetitions per day for a duration of eight weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

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

February 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
Last Updated

July 28, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

June 21, 2025

Last Update Submit

July 23, 2025

Conditions

Keywords

Isometric ExercisesRange of Motion ExercisesPainMobilityFunctional IndependencePost-mastectomy

Outcome Measures

Primary Outcomes (2)

  • Shoulder Pain

    Numeric Pain Rating Scale (NPRS) with decreasing values indicates improved patient condition and reduced pain intensity.

    Eight Weeks

  • Shoulder ROM

    Goniometer with increasing ROM indicates improved patient condition and joint movements.

    Eight Weeks

Secondary Outcomes (1)

  • Shoulder Functional Independence

    Eight Weeks

Study Arms (2)

Isometrics Exercise Group A

EXPERIMENTAL

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.

Procedure: Isometrics Exercise

Range of Motion Exerccise Group B

ACTIVE COMPARATOR

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.

Procedure: Range of Motion Exercises

Interventions

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.

Isometrics Exercise Group A

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

Range of Motion Exerccise Group B

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Experiencing severe pain
  • Diagnosed with advanced lymph edema
  • Physically unable to engage in exercises
  • Medically unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Faisalabad

Faisalābad, Pakistan

Location

MeSH Terms

Conditions

Pain

Interventions

Range of Motion, Articular

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dr Izza Ayub; PT

    Department of Rehabilitaion Sciences, The University of Faisalabad

    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
Principal Investigator

Study Record Dates

First Submitted

June 21, 2025

First Posted

June 29, 2025

Study Start

February 25, 2025

Primary Completion

May 25, 2025

Study Completion

May 25, 2025

Last Updated

July 28, 2025

Record last verified: 2025-02

Locations