| CTRI Number |
CTRI/2023/04/051276 [Registered on: 03/04/2023] Trial Registered Prospectively |
| Last Modified On: |
01/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of diagonal movements of Upper Limb with Theraband Training on Upper Limb Functions in Chronic Obstructive Pulmonary Disease Patients. |
|
Scientific Title of Study
|
Effect of Upper Limb Proprioceptive Neuromuscular Facilitation with Elastic Resistance Band Training on Upper Limb Functions in Chronic Obstructive Pulmonary Disease Patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Md Shahid Raza |
| Designation |
Assistant Professor |
| Affiliation |
Center for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Room no. 106, First floor, Center for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia
New Delhi-110025
Center for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia
New Delhi-110025
South
DELHI
110025
India |
| Phone |
9212156165 |
| Fax |
|
| Email |
mraza1@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Shahid Raza |
| Designation |
Assistant Professor |
| Affiliation |
Center for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Room no. 106, First floor, Center for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia
New Delhi-110025
Center for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia
New Delhi-110025
South
DELHI
110025
India |
| Phone |
9212156165 |
| Fax |
|
| Email |
mraza1@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Mansi Rawat |
| Designation |
Postgraduate Student |
| Affiliation |
Center for Physiotherapy and rehabilitation Sciences |
| Address |
Room no. 02, Ground floor, Ph.D. Research Lab, Center for Physiotherapy and rehabilitation Sciences, Jamia Millia Islamia
Center for Physiotherapy and rehabilitation Sciences, Jamia Millia Islamia, New Delhi
South
DELHI
110025
India |
| Phone |
8448359738 |
| Fax |
|
| Email |
physiomansi3399@gmail.com |
|
|
Source of Monetary or Material Support
|
| Center for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi, 110025, India |
|
|
Primary Sponsor
|
| Name |
Center for Physiotherapy and Rehabilitation Sciences |
| Address |
Jamia Millia Islamia, New Delhi
110025 |
| Type of Sponsor |
Other [Cental University] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Metro center for Respiratory DIseases Metro Group of hospitals |
L-94, near Punjab National Bank, Sector 11, Noida, Uttar Pradesh 201301 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Md Shahid Raza |
Center for Physiotherapy and Rehabilitation Sciences |
Room no. 106, First floor, Gate no. 8, Jamia Millia Islamia, Jamia Nagar, Okhla, New Delhi, Delhi 110025
South
DELHI |
9212156165
mraza1@jmi.ac.in |
| Dr Md Shahid Raza |
Metro Center for Respiratory Diseases, Metro Group of Hospitals. |
Room no. 13, 3rd floor, L-94, Near Punjab National Bank, Sector-11, Noida, Uttar Pradesh, 201301
Gautam Buddha Nagar
UTTAR PRADESH |
9212156165
mraza1@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jamia Millia Islamia |
Approved |
| Metro Ethics Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pulmonary Rehabilitation |
Active range of motion exercises of the upper limb and incremental cycle ergometer. The total duration of the intervention will be 4 weeks. |
| Intervention |
Upper limb training |
Proprioceptive neuromuscular facilitation with elastic resistance band training of the upper limb. The total duration of the intervention will be 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Chronic Obstructive Pulmonary Disease |
|
| ExclusionCriteria |
| Details |
1. Presence of other pulmonary diseases like bronchial asthma, bronchiectasis, interstitial lung disease, and cystic fibrosis.
2. Severe cardiovascular disease or any neurological impairment that could influence the outcomes, such as a recent myocardial infarction.
3. Presence of any mental disease such as cognitive impairment, clinical depression that could influence outcomes, and no history of pharmacologically treated psychiatric disorder.
4. Presence of any type of Orthopedic or musculoskeletal injuries that may compromise the total or partial performance of the movements.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) 10 Repetition Maximum, 2) Upper extremity functional index, 3) Shoulder Endurance test, 4) Respiratory muscle pressure |
pre and post-intervention program of 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cardiopulmonary Exercise Testing, St. George Respiratory Questionnaire |
pre and post intervention program of 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
17/04/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/04/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
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
|
Chronic obstructive pulmonary disease (COPD) is a prevalent, preventable, and curable condition
defined by persistent respiratory symptoms and airflow restriction owing to airway and/or alveolar
abnormalities typically induced by considerable exposure to toxic particles or gases (GOLD,
2017).In 2019, COPD accounted for 3.23 million deaths globally, making it the third-largest cause
of mortality overall.A significant effect of COPD is impairment of peripheral muscle function. Muscle dysfunction, including
decreased maximal strength and endurance, is present in both the upper and lower limbs of COPD
patients. It also
interferes with the contribution of the accessory inspiratory muscles to the work of breathing
during unsupported upper limb activities, there is a larger amount of dyspnea even at low
workloads compared to the lower limb. The upper extremity muscle strength and abdominal muscle endurance and exercise
capacity are reduced compared to healthy subjects in a group of patients with COPD mostly in
GOLD stages II and III and the upper extremity muscle strength is found to be associated with
fatigue perception in COPD. In COPD
patients, it has been seen that resistance training is effective in achieving a muscle training
stimulus, causes an increase in strength and endurance of muscle groups and, statistically
significant improvement in functional capacity and peak workload without distressing dyspnea.Improvements in respiratory mechanics through upper limb training can be made through the use
of resistance exercise employing ERB training in conjunction with PNF as a potential
rehabilitation approach in respiratory diseases. However, it is yet unclear
how well this method improves upper-limb function. PNF with ERB has not been used for upperextremity exercise training in patients with COPD. The purpose of this research is to determine
whether or not PNF combined with ERB improves upper-limb function in people with chronic
obstructive pulmonary disease. |