Breast CancerNCT05873036
Comparison of AT & PR Training to Improve Functional Ability After Breast Cancer Surgery
A study testing Aerobic Training and Progressive Resistance Training in people with Breast Cancer, run by Superior University at 1 site in Pakistan.
Trial summary
To determine the effect of aerobic training and progressive resistance training to improve upper limb functional ability after breast cancer surgery Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Aerobic Training and Progressive Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 31 Aug 2023
- 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 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- a) Breast cancer female survivors eligible under 35-65 years complaining of cancer-related fatigue.
- Adjunctive radiotherapy or underwent surgery (lumpectomy or mastectomy), willing to participate will be included in the study.
- Shoulder pain d) Decreased ROM e) Primary unilateral BC, ALND, no distant metastases, no previous ALND on the contra lateral side f) No previous history of arm lymph edema
Who cannot join
- a) Survivors with other concurrent metastasis anywhere else in the body, diagnosed case of any cardiac or respiratory condition, contra-indicated for exercise training (severe dyspnea, chest pain, severe nausea, ataxia, dizziness etc.) b) Any other neurological or recent musculoskeletal problems were excluded from the study.
- Bilateral mastectomy d) Adjunctive chemotherapy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Chaudhary Muhammad Akram Teaching and research hospital, Jinnah Hospital Lahore and Mayo Hospital Lahore
Lahore, Punjab Province
About this study
Official title: Comparison of Aerobic Training and Progressive Resistance Training to Improve Functional Ability After Breast Cancer Surgery
To determine the effect of aerobic training and progressive resistance training to improve upper limb functional ability after breast cancer surgery
- Conditions
- Breast Cancer
- Being tested
- Aerobic Training, Progressive Resistance Training
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic TrainingDiagnostic test
Aerobic Training to Improve Functional Ability After Breast Cancer Surgery
Progressive Resistance TrainingDiagnostic test
Progressive Resistance Training to Improve Functional Ability After Breast Cancer Surgery
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Training | Other | Not described Receives: Diagnostic Test: Aerobic Training |
| Progressive Resistance Training | Experimental | Not described Receives: Diagnostic Test: Progressive Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical pain rating scale (NPRS)
Measured: 6 Months
Goniometer Tool
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Apr 2023
- Primary completion1 Jun 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873036
- Sponsor's protocol ID
- DPT/Batch-Fall18/547
- Status last verified
- May 2023
- First submitted
- 18 Mar 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Aerobic Training and Progressive Resistance Training to Improve Functional Ability After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT05873036
- Acronym / sponsor ID
- DPT/Batch-Fall18/547
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 24 May 2023 (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.
To determine the effect of aerobic training and progressive resistance training to improve upper limb functional ability after breast cancer surgery
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Training | Other | Diagnostic Test: Aerobic Training |
| Progressive Resistance Training | Experimental | Diagnostic Test: Progressive Resistance Training |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a) Breast cancer female survivors eligible under 35-65 years complaining of cancer-related fatigue.
Key exclusion criteria (2 listed)
- a) Survivors with other concurrent metastasis anywhere else in the body, diagnosed case of any cardiac or respiratory condition, contra-indicated for exercise training (severe dyspnea, chest pain, severe nausea, ataxia, dizziness etc.) b) Any other neurological or recent musculoskeletal problems were excluded from the study.
- Bilateral mastectomy d) Adjunctive chemotherapy
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 |
|---|---|---|
| Aerobic TrainingAerobic Training to Improve Functional Ability After Breast Cancer Surgery | Diagnostic test | Aerobic Training |
| Progressive Resistance TrainingProgressive Resistance Training to Improve Functional Ability After Breast Cancer Surgery | Diagnostic test | Progressive Resistance Training |
Primary outcome
Numerical pain rating scale (NPRS)
Time frame: 6 Months
Goniometer Tool
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Training and Progressive Resistance Training in people with Breast Cancer, run by Superior University 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shama Zahid, DPT (+923134432808, dptm-f18-172@superior.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical pain rating scale (NPRS) (time frame: 6 Months). 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 24 May 2023.