| CTRI Number |
CTRI/2017/08/009530 [Registered on: 29/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
24/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Breathing exercise for Parkinson’s disease patient |
|
Scientific Title of Study
|
Effect of pulmonary rehabilitation on the respiratory muscle strength and functional capacity in patients with parkinsons disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhavana Thakur |
| Designation |
MPT student |
| Affiliation |
Manipal University |
| Address |
Department of physiotherapy, Manipal hospital,No 98, Rustum Bagh
Old Airport Road, HAL
Bangalore
KARNATAKA
560017
India |
| Phone |
9503618207 |
| Fax |
|
| Email |
bhavnasthakur7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
V prem |
| Designation |
Associate professor |
| Affiliation |
Manipal University |
| Address |
Deparment of physiotherapy, Manipal hospital,No 98, Rustum Bagh
Old Airport Road, HAL
Bangalore
KARNATAKA
560017
India |
| Phone |
9886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
V prem |
| Designation |
Associate professor |
| Affiliation |
Manipal University |
| Address |
Department of physiotherapy,Manipal hospital,No 98, Rustum Bagh
Old Airport Road
Bangalore
KARNATAKA
560017
India |
| Phone |
9886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
| School of Allied Health Sciences,Manipal University, Manipal, Udupi- 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal University |
| Address |
Manipal hospital, OLd airport road, HAL, Bangalore |
| 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 |
| Bhavna |
Manipal hospital |
Department of Physiotherapy,Manipal hospital, OLd airport road, HAL
Bangalore
KARNATAKA |
9886647732
bhavnasthakur7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional treatment |
The treatment involves medications as prescribed by the physician |
| Intervention |
Inspiratory muscle training |
subjects in experimental group underwent 8 weeks of intervention of inspiratory muscle training and progressive resisted exercise for 3 sessions in a week. The inspiratory muscle training was given using a pressure threshold device with interval based training program. 21 minutes of session with 2 minutes of work and 1 minute of rest for seven times. The intensity of load was at least more than 30% of initial MIP. The progressive resisted exercises were given for major muscles of upper and lower limb with dumbbell and weight cuffs. The intensity is about 60 – 70% of 1 RM for 10 repetitions of 3 sets for each muscle group |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Subjects complaining of difficulty in breathing, Subjects with ventilatory limitation during physical activity and Subjects with respiratory muscle weakness of maximal inspiratory capacity <60 cmH2O |
|
| ExclusionCriteria |
| Details |
Head injury, Spinal injuries, Marked osteoporosis and fracture rib, Upper and lower limb fractures, Subjects with any acute lung infection of upper or lower respiratory tract infection such as pneumonia, Subjects with airway or lung disease such as asthma or COPD, History of recent lung surgery and Cardiac disease (unstable angina and recent acute myocardial infarction) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Six minute walk test |
pre intervantion
8 weeks post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Maximum inspiratory pressure, chest expansion and pulmonary function test |
Pre intervention
8 weeks post intervention |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
Final Enrollment numbers achieved (Total)= "23"
Final Enrollment numbers achieved (India)="23" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2015 |
| Date of Study Completion (India) |
01/02/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Respiratory Muscle training and Progressive Resisted Exercise are effective in improving the functional capacity of patient with Parkinson’s disease through an improvement in inspiratory muscle strength, chest expansion and by reducing the obstructive part of lung function |