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Trial Title:
Outpatient Versus Tele Rehabilitation Among Post-surgical Breast Cancer Survivors
NCT ID:
NCT06406868
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Shoulder Functional Independece
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Other
Intervention name:
American Cancer Society
Description:
After taking base line readings the patients will be divided into two groups'
experimental group and control group by randomization. The experimental group will
receive tele rehabilitation and the control group will receive outpatient rehabilitation.
Readings will be taken at the end of every week. The treatment plan of both groups will
be the same according to the exercise plan given by American Cancer Society guidelines
for breast cancer patients. The exercise plan will start on third day of surgery. A
pictorial reference will be given to every patient to perform exercise.
The exercise session will be thrice a week, for 60 min, and for four consecutive weeks,
for 12 sessions. Exercise plan consists of three phases:
warm up, balance exercise ,cool down
Arm group label:
Outpatient Rehablitation
Arm group label:
Telerehablitation
Summary:
This study is comparing two interventions to identify effective treatment for breast
cancer patients.
Detailed description:
Tele rehabilitation has gained popularity during Covid 19 pandemic. All the studies
carried out at that time was found effective in many countries. Still a literature gap is
present in tele rehabilitation in breast cancer patients in Pakistan. Prevalence of
breast cancer is high in Pakistan. Now it is the best time to implement tele
rehabilitation for breast cancer patients as it will reduce treatment costs and travel
expenses. Therefore, the goal of this RCT is to consider tele rehabilitation as part of
our treatment plan because if it is found effective for patients than it will be helpful
in the field of health and technology.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 30 to 60 years.
- Breast Cancer Females who underwent mastectomy (Simple total mastectomy).
- Breast Cancer Females without chemotherapy or radiotherapy treatment.
- Accessibility to smart phone.
- Internet access.
Exclusion Criteria:
- Previous history of breast or any other cancer.
- Females with metastatic breast cancer.
- Any Chronic pathology that will result in an increase in symptoms due to physical
exercise.
- Any contraindications limiting physical activity.
- Shoulder radiculopathy, or fracture.
Gender:
Female
Gender based:
Yes
Gender description:
Breast cancer mostly affects females.
Minimum age:
30 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nishtar Hospital
Address:
City:
Multān
Zip:
66000
Country:
Pakistan
Status:
Recruiting
Contact:
Last name:
Qurat-ul-ain Khan, MS
Phone:
0315 5246605
Email:
quratulain.ggc@riphah.edu.pk
Investigator:
Last name:
Leena Shakeel, MS-WHPT
Email:
Principal Investigator
Start date:
February 7, 2024
Completion date:
June 14, 2024
Lead sponsor:
Agency:
Riphah International University
Agency class:
Other
Source:
Riphah International University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06406868