Back to resultsComparison of AT & PR Training to Improve Functional Ability After Breast Cancer Surgery
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Aerobic Training
Progressive Resistance Training
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria: a) Breast cancer female survivors eligible under 35-65 years complaining of cancer-related fatigue. b) Adjunctive radiotherapy or underwent surgery (lumpectomy or mastectomy), willing to participate will be included in the study. c) 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 Exclusion Criteria: - 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. c) Bilateral mastectomy d) Adjunctive chemotherapy
Sites / Locations
- Chaudhary Muhammad Akram Teaching and research hospital, Jinnah Hospital Lahore and Mayo Hospital LahoreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Aerobic Training
Progressive Resistance Training
Arm Description
Outcomes
Primary Outcome Measures
Numerical pain rating scale (NPRS)
Goniometer Tool
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05873036
Brief Title
Comparison of AT & PR Training to Improve Functional Ability After Breast Cancer Surgery
Official Title
Comparison of Aerobic Training and Progressive Resistance Training to Improve Functional Ability After Breast Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Superior University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To determine the effect of aerobic training and progressive resistance training to improve upper limb functional ability after breast cancer surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aerobic Training
Arm Type
Other
Arm Title
Progressive Resistance Training
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Aerobic Training
Intervention Description
Aerobic Training to Improve Functional Ability After Breast Cancer Surgery
Intervention Type
Diagnostic Test
Intervention Name(s)
Progressive Resistance Training
Intervention Description
Progressive Resistance Training to Improve Functional Ability After Breast Cancer Surgery
Primary Outcome Measure Information:
Title
Numerical pain rating scale (NPRS)
Time Frame
6 Months
Title
Goniometer Tool
Time Frame
6 Months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
a) Breast cancer female survivors eligible under 35-65 years complaining of cancer-related fatigue.
b) Adjunctive radiotherapy or underwent surgery (lumpectomy or mastectomy), willing to participate will be included in the study.
c) 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
Exclusion Criteria:
- 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.
c) Bilateral mastectomy d) Adjunctive chemotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shama Zahid, DPT
Phone
+923134432808
Email
dptm-f18-172@superior.edu.pk
Facility Information:
Facility Name
Chaudhary Muhammad Akram Teaching and research hospital, Jinnah Hospital Lahore and Mayo Hospital Lahore
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of AT & PR Training to Improve Functional Ability After Breast Cancer Surgery
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