To see the effect of exercise on bone mineral density changes in children and adolescents with cystic fibrosis

Recruiting

• Conditions: Cystic Fibrosis

• Registration Number: CTRI/2013/04/003531
• Lead Sponsor: Sumita Gupta

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-09
• Last Update Posted: 2013-03-15

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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).
• FEV1 more than or equal to 20%.

Exclusion Criteria

• Patients unwilling to participate in the study.
• Presence of any prior diagnosed musculoskeletal disorder such as rheumatoid arthritis, muscular dystrophy, chronic renal failure.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Bone mineral density	Baseline and at the end of 1year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Out patient department of Deptt. of Pediatrics, Room no.B, All India Institute of Medical Sciences; 🇮🇳 Delhi, DELHI, India

Out patient department of Deptt. of Pediatrics, Room no.B, All India Institute of Medical Sciences

🇮🇳Delhi, DELHI, India

Dr S K Kabra

Principal investigator

09891479796

skkabra@hotmail.com