| CTRI Number |
CTRI/2025/06/089194 [Registered on: 20/06/2025] Trial Registered Prospectively |
| Last Modified On: |
18/06/2025 |
| 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
|
A STUDY TO COMPARE THE IMPACT OF UPPER LIMB AND LOWER LIMB EXERCISE TRAINING IN SUBJECTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE |
|
Scientific Title of Study
|
Impact of Upper limb Vs Lower limb Exercise Training on Respiratory Function in subjects with Chronic Obstructive Pulmonary Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SARASWATHI K |
| Designation |
LECTURER |
| Affiliation |
FACULTY OF PHYSIOTHERAPY,Dr.M.G.R. Educational and Research Institute |
| Address |
FACULTY OF PHYSIOTHERAPY,Dr.M.G.R. Educational and Research Institute,Velappanchavadi,
chennai.
Chennai
TAMIL NADU
600077
India |
| Phone |
8939795549 |
| Fax |
|
| Email |
saraswathi.physio@drmgrdu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.S.RAMACHANDRAN |
| Designation |
PROFESSOR |
| Affiliation |
FACULTY OF PHYSIOTHERAPY,Dr.M.G.R. Educational and Research Institute |
| Address |
Faculty of Physiotherapy,Dr.M.G.R. Educational and Research Institute,Velappanchavadi,
chennai.
Chennai
TAMIL NADU
600077
India |
| Phone |
98410 75381 |
| Fax |
|
| Email |
ramachandran.physio@drmgrdu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
SARASWATHI K |
| Designation |
LECTURER |
| Affiliation |
FACULTY OF PHYSIOTHERAPY,Dr.M.G.R. Educational and Research Institute |
| Address |
FACULTY OF PHYSIOTHERAPY,Dr.M.G.R. Educational and Research Institute,Velappanchavadi,
chennai.
Chennai
TAMIL NADU
600077
India |
| Phone |
8939795549 |
| Fax |
|
| Email |
saraswathi.physio@drmgrdu.ac.in |
|
|
Source of Monetary or Material Support
|
| FACULTY OF PHYSIOTHERAPY,Dr.M.G.R. Educational and Research Institute,Velappanchavadi,Chennai. |
|
|
Primary Sponsor
|
| Name |
K.SARASWATHI |
| Address |
FACULTY OF PHYSIOTHERAPY,Dr.M.G.R. Educational and Research Institute,Velappanchavadi,Chennai. |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| SARASWATHI K |
FACULTY OF PHYSIOTHERAPY,ACS MEDICAL COLLEGE AND HOSPITAL |
OUT PATIENT DEPARTMENT,FACULTY OF PHYSIOTHERAPY,ACS MEDICAL COLLEGE AND HOSPITAL,VELAPPANCHAVADI,
CHENNAI-6000077
Chennai
TAMIL NADU |
8939795549
saraswathi.physio@drmgrdu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,Dr.M.G.R.Educational and Research Institute. |
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 |
INCENTIVE SPIROMETRY,PURSED LIP BREATHING EXERCISE |
INCENTIVE SPIROMETRY-10 REPETITIONS TWICE DAILY FOR 12 WEEKS
PURSED LIP BREATHING EXERCISE-15 MINUTES PER DAY FOR 12 WEEKS |
| Intervention |
UPPER LIMB EXERCISE TRAINING,LOWER LIMB EXERCISE TRAINING |
UPPER LIMB EXERCISE TRAINING-45 MINS/DAY FOR 4 DAYS A WEEK FOR 12 WEEKS
LOWER LIMB EXERCISE TRAINING-
45 MINS/DAY FOR 4 DAYS A WEEK FOR 12 WEEKS |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1.Male persons with an Age group between 40 -50 years
2.Subjects with a clinical diagnosis of moderate COPD, according to the global initiative for chronic obstructive lung disease criteria and with stable condition (that is optimal and stable respiratory medications with no exacerbation or hospital admission within the previous month)
3.Forced Expiratory Volume in first second / Forced vital capacity ratio (FEV1 / FVC) 50-60%.
4.Those who had not attended a pulmonary rehabilitation program in the last year
|
|
| ExclusionCriteria |
| Details |
1.Persons with severe or unstable cardiac disease (eg, left-ventricular failure or atrial fibrillation)
2.Clinically unstable COPD i.e., who presented changes in medication dose or frequency, disease exacerbation or hospital admissions in the preceding 8 weeks.
3.Any other comorbidities (severe cardiovascular, neurological or musculoskeletal conditions)that might influence the execution of exercise.
4.Fracture/any other diseases that prevents upper limb and lower limb exercises
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PULMONARY FUNCTIONS,DYSPNEA,EXERCISE CAPACITY,BMI |
PULMONARY FUNCTIONS,DYSPNEA,EXERCISE CAPACITY,BMI |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| muscle strength |
muscle strength |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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 1 |
|
Date of First Enrollment (India)
|
16/07/2025 |
| 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="6"
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
|
This experimental study aims to evaluate the effects of upper limb training, lower limb training and conventional physiotherapy exercises on respiratory functions in subjects with stable moderate COPD aged 40-50 years.The study will be conducted at the out patient department of Faculty of physiotherpay,ACS Medical College and Hospital,which involves 135 male subjects divided into three groups of 45 participants each, undergoing 45-minute sessions four times weekly over a period of 12 weeks. The primary aim is to investigate the effects of these interventions on pulmonary functions, with the primary objective being a comparative analysis of the impact of upper limb versus lower limb training on pulmonary functions. Secondary objectives include assessing the individual effects of each intervention llike upper limb training, lower limb training and conventional physiotherapy on these parameters. Outcome measures encompass pulmonary functions, dyspnea, exercise capacity, BMI and muscle strength. The results, which will be revealed after the intervention period, are intended to identify the most effective physiotherapy approach for improving respiratory health and functional capacity in subjects with COPD.
|