| CTRI Number |
CTRI/2025/02/080000 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Aerobic training on oral cancer participants with muscle atrophy |
|
Scientific Title of Study
|
Effect of Aerobic training on Muscle strength and Muscle atrophy in Oral cancer patients-a Randomized Controlled Trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruth Nalli |
| Designation |
Master of Physiotherapy |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
R L Jalappa college of physiotherapy, Sri Devaraj Urs Academy of Higher Education and Research
R L Jalappa college of physiotherapy, Sri Devaraj Urs Academy of Higher Education and Research
Kolar
KARNATAKA
563103
India |
| Phone |
7386419711 |
| Fax |
|
| Email |
ruthjoy2626@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
senthil kumar elumalai |
| Designation |
Head of the department / professor |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
R L Jalappa college of physiotherapy, Sri Devaraj Urs Academy of Higher Education and Research
R L Jalappa college of physiotherapy, Sri Devaraj Urs Academy of Higher Education and Research
Kolar
KARNATAKA
563103
India |
| Phone |
7276408001 |
| Fax |
|
| Email |
senthilekumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ruth Nalli |
| Designation |
Master of Physiotherapy |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
R L Jalappa college of physiotherapy, Sri Devaraj Urs Academy of Higher Education and Research
R L Jalappa college of physiotherapy, Sri Devaraj Urs Academy of Higher Education and Research
Kolar
KARNATAKA
563103
India |
| Phone |
7386419711 |
| Fax |
|
| Email |
ruthjoy2626@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Academy of Higher Education and research, tamaka, kolar, karnataka 563103 |
|
|
Primary Sponsor
|
| Name |
Sri Devaraj Urs Academy of Higher Education and research |
| Address |
Sri Devaraj Urs Academy of Higher Education and research, tamaka, kolar, karnataka 563103 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ruth nalli |
Sri Devaraj Urs Academy of Higher Education and research |
R L jalappa college of physiotherapy, department of oncology, R L jalappa hospital, Sri Devaraj Urs Academy of Higher Education and research, tamaka, kolar, karnataka 563103
Kolar
KARNATAKA |
7386419711
ruthjoy2626@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CENTRAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C050||Malignant neoplasm of hard palate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
aerobic training |
moderately intense exercise interventions (50–60% of heart rate maximum, corresponding to a rating of perceived exertion between 11 and 14) |
| Comparator Agent |
no physical training |
patients are not informed anything about aerobic exercises as they can do home based activities without any supervision of physiotherapist |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All types of oral cancer patient.
(Post-operative, receiving chemotherapy and radiation therapy)
Age group between 25 to 60 years.
Who are willing to participate.
Both male and females. |
|
| ExclusionCriteria |
| Details |
individuals with anemia, existence of commodities causing fatigue, infection requiring antibiotics, any medical contraindication. have been engaged in regular physical training, age limit excluding children, cannot understand the instruction or being uncooperative |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Muscle circumference
MMT hand held dynamometer
6 minute walk test
Functional Assessment of Cancer Therapy – Head & Neck (FACT-HN)
|
4 weeks pre and post |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| methylation analysis of PPAR delta gene using PCR method |
pre & post 4 weeks of intervention in experimental group B |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
14/02/2025 |
| 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 Applicable |
| 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
|
Data will be collected based on the inclusion and exclusion criteria. They were informed in detail about the study and a written informed consent will be taken. Patients were randomly included in the groups, 31 each in both the intervention group A in the control group B for 4 weeks. Intervention group A received aerobic exercise program which comprised of a warm up period, conditioning period, cool down period. Control group B were instructed to remain active . Pre and Post data collection of both groups include primary and secondary outcome measures will be collected. |