| CTRI Number |
CTRI/2019/07/020199 [Registered on: 15/07/2019] Trial Registered Prospectively |
| Last Modified On: |
13/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of exercise on post operative breast cancer patients receiving cancer treatments. |
|
Scientific Title of Study
|
Efficacy of aerobic exercise on functional capacity, fatigue and quality of life in post-operative breast cancer patients receiving adjuvant therapy: A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shila Amarsheda |
| Designation |
PhD Scholar |
| Affiliation |
Gujarat University |
| Address |
Navrangpura, Ahmedabad, Gujarat 380009
Ahmadabad
GUJARAT
380058
India |
| Phone |
9974907580 |
| Fax |
|
| Email |
shilaphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjali R Bhise |
| Designation |
I/C Principal, Sr. Lecturer |
| Affiliation |
Gujarat University |
| Address |
Government Physiotherapy College,
Civil Hospital,
Ahmedabad.
Navrangpura, Ahmedabad, Gujarat 380009
Ahmadabad
GUJARAT
380016
India |
| Phone |
9427066624 |
| Fax |
|
| Email |
anjalibhise@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shila Amarsheda |
| Designation |
PhD Scholar |
| Affiliation |
Gujarat University |
| Address |
Navrangpura, Ahmedabad, Gujarat 380009
Ahmadabad
GUJARAT
380058
India |
| Phone |
9974907580 |
| Fax |
|
| Email |
shilaphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gujarat University,
PG section department,
Navrangpura, Ahmedabad. |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Study for PhD thesis ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shila Amarsheda |
Government Physiotherapy College |
Physiotherapy department,
B.J.Medical College, Civil Hospital,Asarwa,Ahmedabad.
Ahmadabad
GUJARAT |
9974907580
shilaphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, B.J.Medical College & Civil Hospital, Ahmedabad. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobic exercise with conventional therapy |
3 times per week lasting for 8 weeks. |
| Comparator Agent |
Conventional therapy |
Conventional Physiotherapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
68.00 Year(s) |
| Gender |
Female |
| Details |
1.Treated for Stage I–III breast cancer by definitive surgery and scheduled to receive outpatient radiation therapy or adjuvant chemotherapy will be eligible for the study,
2.Older than 18 years womens,
3.Ambulatory,
4.No previous history of malignancy,
5.Primary attending oncologist approval |
|
| ExclusionCriteria |
| Details |
1.Uncontrolled cardiac or hypertensive disease,
2.Respiratory disease,
3.Cognitive dysfunction,
4.Musculoskeletal diseases,
5.Neuromuscular disease,
6.Patients already engaged in active exercise, defined as exercising more than 45 min per week. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fatigue |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional Capacity,
Quality of life |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="58" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2019 |
| Date of Study Completion (India) |
25/12/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Exercise during treatment has been recommended for those with cancer to prevent the physiological sequelae of disuse and to maintain function; however, empirical data on exercise response are not available. The purpose of this study was to determine the effect of an aerobic exercise training protocol on the functional capacity, fatigue and quality of life of women receiving adjuvant therapy in post-surgical breast cancer patient. The conclusion of the present study is that aerobic exercise is effective for the management of
functional capacity, fatigue and quality of life in post-operative breast cancer women receiving
adjuvant therapy. Home based aerobic exercise intervention with conventional exercise treatment
leads to significant improvement in functional capacity, reduction in fatigue and improvement in
quality of life compared to conventional exercise alone in post-operative breast cancer women
receiving adjuvant therapy. |