| CTRI Number |
CTRI/2025/11/098019 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nurse-led exercise intervention] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Helping cancer patients manage tiredness through simple nurse-led exercises |
|
Scientific Title of Study
|
Effectiveness of nurse-led exercise on fatigue among patients undergoing cancer treatment. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maidala Muhammad |
| Designation |
Msc nursing |
| Affiliation |
Yenepoya University |
| Address |
Department of Medical-Surgical Nursing (Oncology Division),
Yenepoya Nursing College,
Yenepoya (Deemed to be University), Deralakatte, Mangaluru.
University Road, Deralakatte,
Mangaluru – 575018,
Karnataka, India.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8958891594 |
| Fax |
|
| Email |
muhammadmaidala@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Maidala Muhammad |
| Designation |
Msc nursing |
| Affiliation |
Yenepoya University |
| Address |
Department of Medical-Surgical Nursing (Oncology Division),
Yenepoya Nursing College,
Yenepoya (Deemed to be University), Deralakatte, Mangaluru.
University Road, Deralakatte,
Mangaluru – 575018,
Karnataka, India.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8958891594 |
| Fax |
|
| Email |
muhammadmaidala@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Maidala Muhammad |
| Designation |
Msc nursing |
| Affiliation |
Yenepoya University |
| Address |
Department of Medical-Surgical Nursing (Oncology Division),
Yenepoya Nursing College,
Yenepoya (Deemed to be University), Deralakatte, Mangaluru.
University Road, Deralakatte,
Mangaluru – 575018,
Karnataka, India.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8958891594 |
| Fax |
|
| Email |
muhammadmaidala@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Nursing College,
Yenepoya (Deemed to be University),
Deralakatte, Mangaluru – 575018,
Karnataka, India. — infrastructural support provided.
Self-funded by Principal Investigator (Mr. Maidala Muhammad). |
|
|
Primary Sponsor
|
| Name |
Yenepoya University |
| Address |
Yenepoya Nursing College,
Yenepoya (Deemed to be University),
Deralakatte, Mangaluru – 575018,
Karnataka, India. |
| 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 |
| Dr Habib Rahaman AA |
Yenepoya (Deemed to be University) |
Department of Medical-Surgical Nursing (Oncology Division), Yenepoya Nursing College, University Road, Deralakatte, Mangaluru – 575018, Karnataka, India.
Dakshina Kannada
KARNATAKA |
0824-2206000
medsup@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee - 3 (YEC3) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse-led exercise program |
A structured nurse-led exercise intervention including walking, strengthening exercises using a medicine ball, and range-of-motion (ROM) activities. Conducted twice daily (morning and evening) for 15 days, each session lasting about 10–15 minutes. |
| Comparator Agent |
Routine cancer care (standard care) |
Participants continue receiving their prescribed cancer treatment and supportive care without additional exercise intervention. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are:
1. Diagnosis of solid tumors under active cancer treatment.
2. At least one-month post-diagnosis.
|
|
| ExclusionCriteria |
| Details |
Patients who are:
1. Critically ill patients
2. Patients with physical limitations that hinder exercise performance.
3. Patients already receiving physiotherapy or immediate post-surgical cancer treatment.
4. Patients diagnosed with major psychiatric disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in fatigue score measured by the Piper Fatigue Scale–Revised (PFS-R). |
Day 0 (baseline), Day 7, and Day 15 post-intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Association between fatigue levels and selected demographic variables.
2. Participant adherence and tolerance to nurse-led exercise using Borg RPE Scale.
3. Within- and between-group comparison of fatigue scores (intervention vs. control).
4. Safety and acceptability of nurse-led exercise sessions. |
Baseline (Day 0), Mid-intervention (Day 7), Post-intervention (Day 15), and continuous monitoring during sessions. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
13/12/2025 |
| 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="6"
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
|
Cancer-related fatigue (CRF) is one of the most common and distressing symptoms among patients receiving cancer treatment, significantly affecting physical, emotional and social well-being. Pharmacological options for managing CRF are limited, whereas structured exercise programs have shown promising results in improving energy level and quality of life. This quasi-experimental, non-randomised, active-controlled intervention study aims to assess the effectiveness of a nurse-led exercise program in reducing fatigue among adult cancer patients undergoing treatment in a selected hospital in Mangaluru. A total of 60 (30 intervention, 30 control) participants will be enrolled. The intervention group will receive a structured supervised exercise program that comprises walking, strengthening exercise using a medicine ball and a range of motion activities, conducted twice daily for 15 days. The control group will receive routine cancer care without additional exercise. Fatigue level will be measured using Piper Fatigue Scale-- revised (PFS-R) at baseline (day 0), day 7 and day 15. Data will be analysed using descriptive and inferential statistics to determine the effectiveness of the intervention. The study hypothesises that the nurse-led exercise will significantly reduce fatigue level compared to standard care, supporting the roles of nurses in delivering cost-effective, non-pharmacological interventions in oncology care. |