| CTRI Number |
CTRI/2023/01/049039 [Registered on: 16/01/2023] Trial Registered Prospectively |
| Last Modified On: |
14/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Impact of a supervised exercise program on weakness. fear of falling, fear of movement, life quality and dependence on family and helpers in patients undergoing cytoreductive surgery |
|
Scientific Title of Study
|
Impact of a supervised exercise program on functional outcomes in patients undergoing cytoreductive surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Sharma |
| Designation |
Postgraduate student |
| Affiliation |
SVKMs NMIMS SUNANDAN DIVATIA SCHOOL OF SCIENCE |
| Address |
Department of Physiotherapy, Nanavati Max Super Specialty Hospital, SV Road, Vile Parle (W), Mumbai, India
VL Pherozshah Mehta Road, Vile Parle (W), Mumbai- 400056, India
Mumbai
MAHARASHTRA
400056
India |
| Phone |
9930813356 |
| Fax |
|
| Email |
sharmadivya1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Parulekar |
| Designation |
Assistant Professor |
| Affiliation |
SVKMs NMIMS SUNANDAN DIVATIA SCHOOL OF SCIENCE |
| Address |
Department of Physiotherapy, Nanavati Max Super Specialty Hospital, SV Road, Vile Parle (W), Mumbai, India
VL Pherozshah Mehta Road, Vile Parle (W), Mumbai- 400056, India
Mumbai
MAHARASHTRA
400056
India |
| Phone |
9821820233 |
| Fax |
|
| Email |
Poonam.Parulekar@nmims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Parulekar |
| Designation |
Assistant Professor |
| Affiliation |
SVKMs NMIMS SUNANDAN DIVATIA SCHOOL OF SCIENCE |
| Address |
Department of Physiotherapy, Nanavati Max Super Specialty Hospital, SV Road, Vile Parle (W), Mumbai, India
VL Pherozshah Mehta Road, Vile Parle (W), Mumbai- 400056, India
MAHARASHTRA
400056
India |
| Phone |
9821820233 |
| Fax |
|
| Email |
Poonam.Parulekar@nmims.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Nanavati Max Super Specialty Hospital, SV Road, Vile Parle (W), Mumbai Suburban-400056, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Ali Irani |
Nanavati Max Super Specialty Hospital |
Department of Physiotherapy, Nanavati Max Super Specialty Hospital, SV Road, Vile Parle (W), Mumbai Suburban
Mumbai (Suburban)
MAHARASHTRA |
02226172329
physiodept.nanavati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Dr. Balabhai Nanavati Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Supervised exercise program |
Breathing exercises- namely diaphragmatic breathing, segmental breathing, thoracic mobility exercise, thoracic expansion exercise, Incentive spirometry and early mobilization in ICU following the surgery, continued upto discharge from hospital settings and continued supervision via telerehabilitation for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Undergoing cytoreductive surgery
|
|
| ExclusionCriteria |
| Details |
Comorbidities contributing to fatigue
Age more than 65 years or less than 18 years
Not capable of understanding instructions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Tampa Scale of Kinesiophobia
Functional Independence Measure (FIM) scale
Modified Fatigue Impact scale
SF-36 for quality of life
Vital capacity- using spirometry
2- minute walk test |
Will be measured pre-operatively, Post operatively at the time of discharge (roughly one week post surgery) and at 2 week follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
18/01/2023 |
| 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="0"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Need of study- Patients undergoing abdominal cancer surgery experience significant limitations in functional tasks and activities. Excruciating pain, fatigue, cachexia, weakness, psychological disturbances, depression, anxiety, increased caregiver dependence, etc. are some of the common complaints listed by cancer survivors. Cytoreductive surgery is a commonly used form of abdominal cancer surgery- it is primarily a tumor debulking procedure aimed at reducing the disease burden. We, as physical therapists, are important members of the multidisciplinary team and play a vital role in improving the physical function and quality of life of patients undergoing surgery. Our current study is aimed at understanding the impact of a supervised exercise protocol on functional outcomes in patients undergoing cytoreductive surgery- such as kinesiophobia, fatigue, fear of falls, vital capacity, walking, functional independence and quality of life.
Aim- To understand the impact of a supervised exercise protocol on functional outcomes in patients undergoing cytoreductive surgery
Objectives- 1) To measure the pre operative levels of kinesiophobia, fatigue, fear of falls, functional independence, vital capacity, quality of life and walking 2) To measure the post operative levels of kinesiophobia, fatigue, fear of falls, functional independence, vital capacity, quality of life and walking at the time of discharge 3) To measure the post operative levels of kinesiophobia, fatigue, fear of falls, functional independence, vital capacity, quality of life and walking at the time of follow up
Methodology- Study design- Interventional Study Study samples- Patients undergoing cytoreductive surgery at Nanavati Max Super specialty Hospital, Mumbai Sampling- Convenience sampling Sample size- determined using OpenEpi software- 95% confidence level and 5% margin of error- estimated sample size is 55.
Procedure- - Ethical clearance obtained from the institutional ethics committee
- Screening of subjects using inclusion and exclusion criteria
- Obtaining written informed consent from subjects selected
- Pre operative recording of outcome measures and teaching the exercises to the subject
- Post operatively following the exercise protocol (as mentioned below)
- Noting the outcomes at the time of discharge
- Supervised telerehabilitation session of 2 weeks, i.e. 3 sessions per week
- Noting the outcomes at the end of 2 weeks of telerehabilitation
- Compiling the data
- Data Analysis
- Conclusions
The proposed exercise protocol is as follows-
Pre operatively- Teach the patient- Diaphragmatic breathing, segmental breathing, thoracic mobility exercises, thoracic expansion exercises - 10 repetitions each Splinted FET (forced expiratory technique- coughing) Incentive spirometry- 10 repetitions * 3 sets 2 minute walk test
Post operative day 1- morning session- Diaphragmatic breathing, segmental breathing, thoracic mobility exercises, thoracic expansion exercises - 10 repetitions each Splinted FET (forced expiratory technique- coughing) Incentive spirometry- 10 repetitions * 3 sets Mobilization to the edge of bed with the support of abdominal binder, and backrest
Post operative day 1- afternoon session- Diaphragmatic breathing, segmental breathing, thoracic mobility exercises, thoracic expansion exercises - 10 repetitions each Splinted FET (forced expiratory technique- coughing) Incentive spirometry- 10 repetitions * 3 sets Mobilization to walk as per tolerance and chair sitting
Post operative day 2 --- up to discharge from hospital setting Diaphragmatic breathing, segmental breathing, thoracic mobility exercises, thoracic expansion exercises - 10 repetitions each Splinted FET (forced expiratory technique- coughing) Incentive spirometry- 10 repetitions * 3 sets Mobilization to walk and chair sitting- as per patient tolerance- progressing the distance walked in all subsequent sessions
Telerehabilitation- three sessions per week for two weeks
Week 1
Diaphragmatic breathing, segmental breathing, thoracic mobility exercises, thoracic expansion exercises - 10 repetitions each Splinted FET (forced expiratory technique- coughing) Incentive spirometry- 10 repetitions * 3 sets Spot marching- 1 min (with gradually increased time as per tolerance) Mobilization to walk and chair sitting- as per patient tolerance- progressing the distance walked in all subsequent sessions
week 2
Diaphragmatic breathing, segmental breathing, thoracic mobility exercises, thoracic expansion exercises - 10 repetitions each Splinted FET (forced expiratory technique- coughing) Incentive spirometry- 10 repetitions * 3 sets Spot marching- 1 min (with gradually increased time as per tolerance) Mobilization to walk and chair sitting- as per patient tolerance- progressing the distance walked in all subsequent sessions Stair climbing 1 flight of stairs- progressed as per tolerance |