| CTRI Number |
CTRI/2018/01/011058 [Registered on: 01/01/2018] Trial Registered Prospectively |
| Last Modified On: |
08/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of exercise in patients with head and neck cancer receiving Chemoradiation therapy. |
|
Scientific Title of Study
|
Effect of Aerobic versus Progressive resistance training on functional capacity and quality of life in head and neck cancer patients receiving chemoradiotherapy-A Randomized clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TANDRA RACHANA REDDY |
| Designation |
Post Graduation |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
KMC Hospital,Attavar,
Mangaluru,Karnataka.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7674022551 |
| Fax |
|
| Email |
rachana2593@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Stephen R Samuel |
| Designation |
Assistant professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy,KMC,Mangaluru.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9909539145 |
| Fax |
|
| Email |
stephen.samuel@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr PU Saxena |
| Designation |
Associate professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Kasturba Medical College,Manipal Academy of Higher Education,Mangaluru,Karnataka.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9008761002 |
| Fax |
|
| Email |
pu.saxena@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of higher Education,Mangaluru,Karnataka. |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Manipal Academy of Higher Education,Mangaluru. |
| Type of Sponsor |
Private 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 |
| TANDRA RACHANA REDDY |
KMC Hospital |
Department of Physiotherapy,Second Floor,Attavar,
Mangaluru,Karnataka.
Dakshina Kannada
KARNATAKA |
7674022551
rachana2593@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,KMC,MANGALURU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Head and neck cancer patients receiving chemoradiotherapy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobic Exercise |
Brisk walking for 15-20 minutes for a period of seven weeks |
| Comparator Agent |
Progressive Resistance Training. |
Progressive resistance training is given with resistance bands for major muscle groups for a period of seven weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with head and neck cancer(STAGE III,IVa AND IVb) receiving chemoradiotherapy with Eastern Cooperative Oncology Group (ECOG) Score <2. |
|
| ExclusionCriteria |
| Details |
1.Patients with severe Orthopaedic and Neurological problems.
2.Inability to comply with study procedures.
3.Patients contraindicated to exercise training.
4.Platelet Count<30000/ul.
5.HB Count< 8 gm/dl |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Functional capacity and Quality of life |
baseline,3rd week and 7th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| fatigue and skeletal muscle mass |
baseline,3rd week and 7th week |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
01/01/2018 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
AIM OF THE STUDY: The study aims to compare the effect of aerobic training versus progressive resistance training on functional capacity and quality of life in patients with head and neck cancer receiving chemoradiation therapy. SIGNIFICANCE OF THE STUDY: This study will help us to ascertain the optimal type of exercise for this patient population.This study will help us to know whether aerobic training or progressive resistance training helps us to improve the functional capacity and quality of life in patients with head and neck cancer. PROCEDURE:Patients with head and neck cancer receiving chemoradiation therapy will be explained about the study and willing participants will be signing a written informed consent and are screened based on study criteria.Following randomly allocated through computer generated sequence into group A and group B.Group A will receive aerobic training(brisk walking) for 15-20 minutes, 5 days per week for a period of seven weeks.Group B will receive aerobic training 15-20 minutes, 5 days a week ;along with progressive resistance training with resistance band for 10-15 min ,3 days a week for a period of seven weeks.Functional capacity, Quality of life,Fatigue and Skeletal muscle mass are assessed at base line,3 weeks and at 7th week. |