| CTRI Number |
CTRI/2013/04/003531 [Registered on: 04/04/2013] Trial Registered Retrospectively |
| Last Modified On: |
15/03/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of exercise on bone mineral density changes in children and adolescents with cystic fibrosis |
|
Scientific Title of Study
|
Effects of exercise intervention program on bone mineral accretion in children and adolescents with cystic fibrosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumita Gupta |
| Designation |
Physiotherapist |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Pediatrics, AIIMS, Ansari Nagar, New Delhi
Department of Pediatrics, AIIMS, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
09810147877 |
| Fax |
|
| Email |
sumitabisoi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S K Kabra |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Pediatrics, AIIMS, Ansari Nagar, New Delhi
Department of Pediatrics, AIIMS, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
09891479796 |
| Fax |
|
| Email |
skkabra@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sumita Gupta |
| Designation |
Physiotherapist |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Pediatrics, AIIMS, Ansari Nagar, New Delhi
Department of Pediatrics, AIIMS, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
09810147877 |
| Fax |
|
| Email |
sumitabisoi@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Ansari Nagar,New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
Sumita Gupta |
| Address |
Department of Paediatrics,AIIMS, Ansari Nagar,New Delhi-110029 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| All India Institute of Medical Sciences |
Ansari Nagar, New Delhi-110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S K Kabra |
Out patient department of Deptt. of Pediatrics, Room no.B, All India Institute of Medical Sciences |
Deptt. of Pediatrics O.P.D, Room no.B,All India Institute of Medical Sciences, Ansari Nagar,New Delhi-110029
New Delhi
DELHI |
09891479796
skkabra@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Commite/Ethics Sub-Committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cystic Fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exercise program |
Resistance exercise and plyometric jumping exercise
Once a day, 3 times a week for one year |
| Comparator Agent |
No exercise program |
Continue with regular physical activity for one year |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.Children with confermed diagnosis of cystic fibrosis (sweat chloride more than or equal to 60 mEq/l on 2 or more occasions in a child with clinical features suggestive of cystic fibrosis.
2.With stable medical condition (not required i.v.antibiotics for last one month prior to enrollment).
3. FEV1 more than or equal to 20%. |
|
| ExclusionCriteria |
| Details |
1. Patients unwilling to participate in the study.
2. Presence of any prior diagnosed musculoskeletal disorder such as rheumatoid arthritis, muscular dystrophy, chronic renal failure. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean Bone mineral density |
Baseline and at the end of 1year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Forced expiratory volume during first second, Forced vital capacity |
Baseline, 3 months, 6 months, 9 months and at the end of one year |
| Exercise Capacity |
Baseline and at the end of one year |
| Cystic fibrosis questionnaire-revised |
Baseline and at the end of one year |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
08/09/2012 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
It is a randomized, parallel group trial, to study the effect of exercise intervention in children and adolescents, aged 6-18 years, with cystic fibrosis, that would be conducted in the Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India. The primary outcome measure is mean bone mineral density at baseline and at the end of one year. The secondary outcome measures are 1. FEV1 and FVC at baseline, 3 months, 6 months, 9 months, and at the end of 1 year 2. Exercise Capacity at baseline and at the end of one year 3. Quality of life as assessed by Cystic Fibrosis questionnaire- revised at baseline and at the end of 1 year |