| CTRI Number |
CTRI/2017/08/009479 [Registered on: 23/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
08/07/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of strength and endurance of deep abdominal stability muscles in people with chronic respiratory disease and people without respiratory disease. |
|
Scientific Title of Study
|
Comparison of core muscle strength and endurance in patients with Chronic Obstructive Pulmonary Disease (COPD) and Non-COPD subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ambika Lama |
| Designation |
post graduate student |
| Affiliation |
School of Allied Health Sciences, Manipal University |
| Address |
Department of Physiotherapy, School of Allied Health Science, Manipal University, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9686794059 |
| Fax |
|
| Email |
aambikalama@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali K |
| Designation |
Professor and Head Dept. of Physiotherapy |
| Affiliation |
School of Allied Health Sciences, Manipal University |
| Address |
Department of Physiotherapy, School of Allied Health Science, Manipal University, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202922880 |
| Fax |
|
| Email |
vaishali.k@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ambika Lama |
| Designation |
post graduate student |
| Affiliation |
School of Allied Health Sciences, Manipal University |
| Address |
Department of Physiotherapy, School of Allied Health Science, Manipal University, Manipal
Sharada Hostel, Manipal Campus, Manipal University, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9686794059 |
| Fax |
|
| Email |
aambikalama@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, School Of Allied Health Sciences, Manipal University, Manipal- 576104 |
|
|
Primary Sponsor
|
| Name |
Dept of Physiotherapy |
| Address |
Dept. of Physiotherapy, School of Allied health Science, Manipal |
| 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 |
| Ambika Lama |
Kasturba Hospital |
3rd floor, Fitness Unit, Department of Physiotherapy,Old SOAHS building, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
9686794059
aambikalama@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non- COPD |
| Patients |
Chronic Obstructive Pulmonary Disease, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Physician diagnosed COPD
Moderate COPD (GOLD criteria FEV1 50%- 80% of predicted)
Stable COPD patients
|
|
| ExclusionCriteria |
| Details |
H/o any neurological deficits
H/o severe Pulmonary arterial hypertension (>60mmHg)
H/o LV Ejection fraction < 50%
H/o recent abdominal surgery (upper and lower)
H/o Pelvic organ prolapse, hysterectomy, benign prostatic hyperplasia
H/o diagnosed low back pain
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| strength of core muscles by using Manual Muscle Testing Grades, and endurance by using Pressure Biofeedback for abdominals and multifidi muscles. strength of diaphragm by using Micro RPMeter, by taking MIP (maximum inspiratory pressure) |
One Time Study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hip abductor strength by using hand held dynamometer.Pelvic floor muscle strength and function by using Urogenital Distress Inventory-6 |
one time |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
03/04/2017 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Core muscles are important for spinal stability, and postural balance. Adequate
strength and endurance of core muscles are important to maintain posture and
perform any functional activity efficiently. It is found that good posture is
associated with breathing pattern. Indirectly, core muscle may be
affected when there is altered breathing pattern and chronic altered posture in
COPD. However, peripheral muscle strength is reduced in chronic airway disease,
but there is scarcity of literature about core muscles strength in COPD. |