Post MastectomyNCT07043959
Comparative Effects of Isometrics Versus Range of Motion Exercises on Pain, Mobility and Functional Independence in Post-Mastectomy Patients
A study testing Isometrics Exercise and Range of Motion Exercises in people with Post Mastectomy and Postmastectomy Pain, run by University of Faisalabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Post Mastectomy, Postmastectomy Pain
- What is being tested?
- Isometrics Exercise and Range of Motion Exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Feb 2025to 25 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Experiencing severe pain
- Diagnosed with advanced lymph edema
- Physically unable to engage in exercises
- Medically unstable
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Post Mastectomy, Postmastectomy Pain
- Being tested
- Isometrics Exercise, Range of Motion Exercises
- Keywords
- Isometric Exercises, Range of Motion Exercises, Pain, Mobility, Functional Independence, Post-mastectomy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometrics ExerciseProcedure or surgery
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.
Range of Motion ExercisesProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Range of Motion Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain
Numeric Pain Rating Scale (NPRS) with decreasing values indicates improved patient condition and reduced pain intensity.
Measured: Eight Weeks
Shoulder ROM
Goniometer with increasing ROM indicates improved patient condition and joint movements.
Measured: Eight Weeks
Secondary outcomes (1)
Shoulder Functional Independence
Upper Extremity Functional Scale determines the level of function of participant where higher score indicates improved upper extremity function and reduced functional impairment.
Measured: Eight Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start25 Feb 2025
- Primary completion25 May 2025
- Study completion25 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post MastectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Izza Ayub; PT, University of Faisalabad
- Investigators
- Dr Izza Ayub; PT, Principal investigator, Department of Rehabilitaion Sciences, The University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043959
- Sponsor's protocol ID
- TUF/PB/40/1033/40
- Status last verified
- Feb 2025
- First submitted
- 21 Jun 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Isometrics Versus Range of Motion Exercises on Pain, Mobility and Functional Independence in Post-Mastectomy Patients
- ClinicalTrials.gov ID
- NCT07043959
- Acronym / sponsor ID
- TUF/PB/40/1033/40
- Conditions
- Post Mastectomy, Postmastectomy Pain
- Keywords
- Isometric Exercises, Range of Motion Exercises, Pain, Mobility, Functional Independence, Post-mastectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 25 May 2025 (actual)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isometrics Exercise Group A | Experimental | Procedure: Isometrics ExerciseGroup 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. |
| Range of Motion Exerccise Group B | Active comparator | Procedure: Range of Motion ExercisesGroup 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Experiencing severe pain
- Diagnosed with advanced lymph edema
- Physically unable to engage in exercises
- Medically unstable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometrics ExerciseShoulder 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. | Procedure or surgery | Isometrics Exercise Group A |
| Range of Motion ExercisesWall 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 | Procedure or surgery | Range of Motion Exerccise Group B |
Primary outcome
Shoulder Pain
Time frame: Eight Weeks
Numeric Pain Rating Scale (NPRS) with decreasing values indicates improved patient condition and reduced pain intensity.
Shoulder ROM
Time frame: Eight Weeks
Goniometer with increasing ROM indicates improved patient condition and joint movements.
1 secondary outcome
Shoulder Functional Independence
Time frame: Eight Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Izza Ayub; PT principal investigator
Department of Rehabilitaion Sciences, The University of Faisalabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometrics Exercise and Range of Motion Exercises in people with Post Mastectomy and Postmastectomy Pain, run by University of Faisalabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain (time frame: Eight Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.