| CTRI Number |
CTRI/2022/04/041749 [Registered on: 08/04/2022] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
In-Target study |
|
Scientific Title of Study
|
Pulmonary and Extra-Pulmonary Profile of Chronic Obstructive Pulmonary Disease among Asian Indian population: Impact of Nutrition and Tele-Assisted Rehabilitation with Guided Exercise Training Study (In-Target study) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohini Bhadra |
| Designation |
PhD Fellow |
| Affiliation |
St Johns Medical College & St Johns Research Institute |
| Address |
Room no 401 3rd floor Robert Koch Bhavan Division of Nutrition Department of Physiology St Johns Medical College Marathahalli Sarjapur Rd beside Bank Of Baroda John Nagar Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
08049466301 |
| Fax |
|
| Email |
rohini.b@sjri.res.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sucharita S |
| Designation |
Professor & Head, Department of Physiology |
| Affiliation |
St Johns Medical College |
| Address |
3rd floor Robert Koch Bhavan Department of Physiology St Johns Medical College Marathahalli Sarjapur Rd beside Bank Of Baroda John Nagar Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
08049466591 |
| Fax |
|
| Email |
sucharita@stjohns.in |
|
Details of Contact Person
Public Query
|
| Name |
Rohini Bhadra |
| Designation |
PhD Fellow |
| Affiliation |
St Johns Medical College & St Johns Research Institute |
| Address |
Room no 401 3rd floor Robert Koch Bhavan Division of Nutrition Department of Physiology St Johns Medical College Marathahalli Sarjapur Rd beside Bank Of Baroda John Nagar Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
08049466301 |
| Fax |
|
| Email |
rohini.b@sjri.res.in |
|
|
Source of Monetary or Material Support
|
| St Johns Research Institute, 100 Feet Rd, John Nagar, Koramangala, Bengaluru, Karnataka 560034 |
|
|
Primary Sponsor
|
| Name |
St Johns Research Institute |
| Address |
100 Feet Rd, John Nagar, Koramangala, Bengaluru, Karnataka 560034 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Rohini Bhadra |
St Johns Medical College Hospital |
Room no 401 3rd floor Robert Koch Bhavan Department of Physiology St Johns Medical College Marathahalli Sarjapur Rd beside Bank Of Baroda John Nagar Koramangala
Bangalore
KARNATAKA |
08049466301
rohini.b@sjri.res.in |
|
Details of Ethics Committee
Modification(s)
|
| 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 |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Tele-assisted resistance exercise and nutritional support |
1. 3 weekly video guided resistance exercise sessions that can be performed while being seated on a chair using a resistance band(30-40 min each sessions)
2. Personalized nutritional counselling on recruitment.
Consumption of daily oral nutritional supplement (protein and micronutrient rich) to meet 20-25% of patients requirement.
3. Weekly tele-health consultation with lifestyle coach on general well-being, progress and compliance
Total duration of intervention: 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
COPD patients with FEV1/FVC <0.7
Age 45 years to 80 years
both male and female, all BMI categories
Smokers and non-smokers
|
|
| ExclusionCriteria |
| Details |
History of active cardiovascular disease with surgical intervention
Malignancy, hepatic or renal insufficiency
History of major surgery, anaemia or tuberculosis in previous 6 months
History of injury in past 3 months that significantly affect physical functionality
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life measured using standard questionnaires, i.e.EuroQol5DL, St George Respiratory Questionnaire (SGRQ) |
Post intervention measure after completion of 8 weeks intervention.
Follow up at 16 weeks, 24 weeks and 1 year post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pulmonary function: FEV1, FVC, ratio of FEV1/ FVC
Emphysema and muscle and adipose tissue mass and distribution on L1 and pectoralis (mm) measured by quantitative chest CT
Biochemical parameters: Blood sugar, lipid profile, urea, creatinine, erythrocyte sedimentation rate (ESR)
Anthropometric measurements: Height, weight, waist circumference, hip circumference, mid upper arm circumference, calf circumference
Body composition: % lean mass, appendicular muscle mass, bone density (DEXA)
Muscle function: handgrip strength, lower limb muscle function (handheld dynamometer, Isokinetic dynamometer)
Functional capacity: 6 min walk test (6MWT)
Physical activity level (PAL): PAL questionnaire
Hospital Anxiety and Depression Scale Questionnaire for mental health |
after completion of 8 weeks intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
18/04/2022 |
| 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="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pulmonary rehabilitation is an integral part of comprehensive COPD management. It has shown beneficial results in improving multiple COPD associated symptoms including a reduction in dyspnoea, exacerbation frequency, recurrent hospitalization and improvement in functional capacity, muscle strength and quality of life. The utilisation of pulmonary rehabilitation in the Indian setup is limited due to multiple constraints including space, expenditure, manpower and resources. Considering these challenges, this study has developed a structured rehabilitation program consisting of exercises, nutritional and motivational support that can be delivered in the patient’s home environment. A video-based exercise module will be created for the patients aided with weekly telehealth follow-up calls from the study investigator. The participants will receive personalised nutritional counselling along with a nutritional supplement for regular consumption, designed to address frequently prevalent malnutrition observed in the patients. Weekly telephonic sessions will be made for reinforcement of the benefits of lifestyle changes, gather information on patient wellbeing, compliance and progress on the program. The aim of the study is to evaluate the short-term and long-term effectiveness of a structured telehealth intervention on the overall quality of life of patients seen in a hospital setting in Karnataka, India |