FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/01/048813 [Registered on: 09/01/2023] Trial Registered Prospectively
Last Modified On: 03/01/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Effect of exercise on bone health for arm swelling after breast cancer  
Scientific Title of Study   Effects of a resistance training program on the bone mineral density in patients with breast cancer related lymphedema - a preliminary quasi experimental study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nivedita S Prabhu 
Designation  Assistant Professor -Selection Grade 
Affiliation  Manipal College of Health Professions  
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  09901729546  
Fax    
Email  nivedita.kamath@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Nivedita S Prabhu 
Designation  Assistant Professor -Selection Grade 
Affiliation  Manipal College of Health Professions  
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal.

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  nivedita.kamath@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Nitika Panakkal  
Designation  Assistant Professor - Selection Grade 
Affiliation  Manipal College of Health Professions  
Address  Department of Medical Imaging Technology, Manipal College of Health Professions, Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  nitika.cp@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education  
Address  Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka, India -576104 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Nivedita S Prabhu  Kasturba Hospital, Manipal  Division of Physiotherapy Oncology out patient clinic, Department of Physiotherapy.
Udupi
KARNATAKA 		 9901729546

nivedita.kamath@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable   Not Applicable  
Intervention  Resistance Training program   Graded resistance exercises will be administered for 12 weeks using therabands for the affected upper limb with lymphedema  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Breast cancer survivors with upper limb lymphedema after:
1. breast conservative surgery
2. modified radical mastectomy with axillary node dissection (levels I and II),
3. adjuvant chemotherapy and radiotherapy and
hormonal therapy
 
 
ExclusionCriteria 
Details  Participants unable to follow instructions
1. Musculoskeletal disorders (rheumatoid arthritis, fragility fractures involving upper limb, compartment syndrome) in which exercises cannot be performed.
2. Clinical evidence of impaired peripheral vascular circulation in affected limb with BCRL
3. Clinical evidence of acute cellulitis in affected limb with BCRL
4. End stage organ failure (renal, cardiac, hepatic)
5. Left ventricular ejection fraction < 25% with s/o congestive cardiac failure
6. Severe valvular heart disease
7. Participants with any acute illness
8. Stage IV breast cancer (ECOG score > 2)
9. Bilateral upper limb lymphedema
10. Participants receiving pharmacological treatment for osteoporosis and bone health
11. Participants on steroid therapy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Bone mineral density (T-score)
 		 Time point 1 - Day 0 (Baseline)
Time point 2 - Day 90 (Post Intervention) 
 
Secondary Outcome  
Outcome  TimePoints 
Limb Girth (ml)
Upper Limb function  		 Time point 1 - Day 0 (Baseline)
Time point 2 - Day 90 (Post Intervention) 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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   Phase 3 
Date of First Enrollment (India)   10/01/2023 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This single arm, single centered quasi experimental study will study the effects of resistance exercises for 12 weeks on the bone mineral density, limb girth and upper limb function in breast cancer patients or breast cancer survivors diagnosed with breast cancer related lymphedema. The outcomes will be assessed pre and post intervention (exercise training program).  
Close