Ruddy 2011.
Methods | Randomised, open‐label, parallel study. |
Participants | Estimated enrolment: 20. Ages: 12 ‐ 25 years. |
Interventions | Active comparator: yoga (immediate start) group. This arm will start yoga sessions immediately after screening and will continue sessions for 8 weeks. This group will then continue with home yoga for an additional 8 weeks. Active comparator: Yoga (waitlist) group. This arm will continue regular CF therapies for 8 weeks and will start yoga sessions at week 9. |
Outcomes |
Primary outcome measures 1. Number of participants with adverse events as a measure of safety 2. Pain scores on the Visual Analog Scale as a measure of tolerability Participants will be given a tolerance questionnaire after each yoga session which will assess their degree of musculoskeletal and chest pain on a visual analog scale. Vital signs will also be measured before and after each yoga session. Secondary outcome measures 1. QoL 2. Respiratory symptoms 3. Treatment adherence 4. Pulmonary function 5. Ease of breathing 6. BMI |
Notes | Start date: February 2011, estimated end date: October 2011. Country: USA. |