| CTRI Number |
CTRI/2024/07/069841 [Registered on: 03/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Difference of physical fitness functions between women with breast cancer and healthy women |
|
Scientific Title of Study
|
Comparison of physical fitness parameters between women with breast cancer and matched healthy controls |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Komal |
| Designation |
PG Student |
| Affiliation |
College of Physiotherapy, PGIMS, Rohtak |
| Address |
Physiotherapy Department, E-Block, College of Physiotherapy, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9729373739 |
| Fax |
|
| Email |
komalgakkhar04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Mehra |
| Designation |
Assistant Professor |
| Affiliation |
College of Physiotherapy, PGIMS, Rohtak |
| Address |
Physiotherapy Department, Teaching Staff Room, E-Block, College of Physiotherapy, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8814063412 |
| Fax |
|
| Email |
sumanmehra2017@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Mehra |
| Designation |
Assistant Professor |
| Affiliation |
College of Physiotherapy, PGIMS, Rohtak |
| Address |
Physiotherapy Department, Teaching Staff Room, E-Block, College of Physiotherapy, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8814063412 |
| Fax |
|
| Email |
sumanmehra2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India, 124001 |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy, PGIMS, Rohtak |
| Address |
Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India, 124001 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Suman Mehra |
Pt. B.D. Sharma PGIMS |
Physiotherapy Department, E-Block, College of Physiotherapy, Pt. B.D. Sharma PGIMS/UHS, Rohtak
Rohtak
HARYANA |
8814063412
sumanmehra2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee(BREC) PGIMS/UHS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age matched control |
| Patients |
(1) ICD-10 Condition: D249||Benign neoplasm of unspecified breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1. Women diagnosed with breast cancer who are either on active treatment or completed it.
2. Subjects with healed scar in case of surgical treatment. |
|
| ExclusionCriteria |
| Details |
1. Subjects who are unstable medically with uncontrolled hypertension and cardiac illness.
2. Subjects with incomplete healing of any wound or with cellulites.
3. Subjects with metastasis to brain and bones.
4. Subjects who refuse to give consent.
5. Subjects with severe frailty.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Arm curl field test, Apley’s scratch test, 6-minute walk test, Ruler drop test |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional reach test, 30s Chair stand test |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: Comparison of physical fitness parameters between
women with breast cancer and matched healthy controls
30 sample size
Inclusion and Exclusion criteria mentioned above
Cross-sectional Observational Study
|