| CTRI Number |
CTRI/2024/05/066797 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| 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
|
Exploring the Impact of Energy Conservation Techniques on Chronic Respiratory Conditions |
|
Scientific Title of Study
|
Effect of Energy Conservation Techniques on Fatigue, Quality of life and Activity Participation in individuals with Chronic Respiratory Diseases: A Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muskan Sharma |
| Designation |
Post Graduate Resident |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
First floor, Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, 11/12 Thube Park, Shivajinagar, Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
7710005827 |
| Fax |
|
| Email |
muskan7799@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prajakta Sahasrabudhe |
| Designation |
Professor and HOD |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
First floor, Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, 11/12 Thube Park, Shivajinagar, Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9930677920 |
| Fax |
|
| Email |
prajakta.sahasrabudhe2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Muskan Sharma |
| Designation |
Post Graduate Resident |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
First floor, Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, 11/12 Thube Park, Shivajinagar, Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
7710005827 |
| Fax |
|
| Email |
muskan7799@gmail.com |
|
|
Source of Monetary or Material Support
|
| First floor, Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, 11/12 Thube Park, Shivajinagar, Pune
|
|
|
Primary Sponsor
|
| Name |
Muskan Sharma |
| Address |
First floor, Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, 11/12 Thube Park, Shivajinagar, Pune
Pune
MAHARASHTRA
411005
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 Muskan Sharma |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
First floor, Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, 11/12 Thube Park, Shivajinagar, Pune
Pune
MAHARASHTRA |
7710005827
muskan7799@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute for Orthopaedics and Rehabilitation Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J40-J47||Chronic lower respiratory diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Pulmonary Rehabilitation protocol |
The comparator agent is the control group which includes conventional pulmonary rehabilitation protocol. It’ll be given for 40mins, in 3sessions/week for 3weeks |
| Intervention |
Energy Conservation Techniques + Conventional Pulmonary Rehabilitation protocol |
The intervention includes an in person supervised 40 mins protocol for 3 sessions/week given for 3weeks. It includes energy conservation stratergies along with conventional pulmonary rehabilitation. The strategies will be used for comprehensive EDUCATIVE + TASK SPECIFIC TRAINING sessions of the participants where the emphasis will be on the activities of daily living (ADLs) causing them the maximum amount of distress. Activities from the self care, mobility and recreational domains will be selected |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinically diagnosed chronic respiratory conditions |
|
| ExclusionCriteria |
| Details |
Patients who are –
1. On oxygen therapy
2. Immobilized or bed ridden
3. Not hemodynamically stable
4. Having any malignant diseases
5. Having neurological, musculoskeletal or cardiac diseases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oxford Participation and Activities Questionnaire (Ox-PAQ) |
At baseline (0 weeks) and after intervention (3 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Chronic Respiratory Disease Questionnaire (CRQ) |
At baseline (0 weeks) and after intervention (3 weeks) |
| Fatigue Severity Scale (FSS) |
At baseline (0 weeks) and after intervention (3 weeks) |
| Borg CR10 Scale |
At baseline (0 weeks) and after intervention (3 weeks) |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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 2 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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 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
|
With the knowledge that most common chronic diseases like COPD, asthma,
pulmonary fibrosis are not curable, permanent and irreversible; there is a need to focus on enhancing functional status and minimizing
distressing symptoms like fatigue and dyspnea, which might be related to
improvement in quality of life and enhanced participation in these patients.
Energy conservation (or energy management) strategies
are a well-known intervention in the fatigue rehabilitation of patients.
Energy conservation involves changing an activity or
the environment to decrease the level of energy required to complete a task.
The goal is to improve a person’s ability to manage his/her fatigue throughout
an entire day. With proper use, an individual can decrease their overall level
of fatigue while still being able to perform daily tasks and routines at home,
at work, and in community.
Null Hypothesis (Hâ‚€) - There are no additional effects of incorporating energy conservation techniques with conventional pulmonary rehabilitation on fatigue, quality of life and activity participation in individuals with chronic respiratory diseases. Alternate Hypothesis (Hâ‚) - There are additional effects of incorporating energy conservation techniques with conventional pulmonary rehabilitation on fatigue, quality of life and activity participation in individuals with chronic respiratory diseases.
|