Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Steps Ahead: Optimising Physical Activity and Health in Adults With Cystic Fibrosis
Brief Summary: Physical activity is widely documented as one of the cornerstones of Cystic Fibrosis (CF) management as it is directly linked to mortality and quality of life. Levels of physical inactivity and sedentary behaviour have been poorly investigated among the CF population in Ireland. The measurement of these behaviours is important in order to monitor prevalence amongst people with CF (PWCF) and determine methods by which health care providers can assist with maintaining and enhancing physical activity.

The use of physical activity monitoring can provide health care providers with insightful real world analysis of physical activity and exercise behaviours. Over the last decade there has been many advancements in technology and fitness tracking with positive results being demonstrated in the healthy population and in chronic diseases such as Diabetes Mellitus II, post surgery and Multiple Sclerosis. Limited research has been conducted among PWCF to date.

The aim of this research project is to examine physical activity levels amongst PWCF and determine the effect of a 12 week randomised parallel intervention on a number of health outcomes.

Participants will be provided with an accelerometer to assess physical activity and sedentary behaviour at baseline. The participants will then undergo further baseline testing to determine exercise capacity, body composition, quality of life, breathlessness, sleep quality and wellbeing. Baseline short and long term goals will be established together with the participant and physiotherapist.

Participants will then be randomly allocated to either the intervention or the comparator. A researcher independent of the recruitment process (MC) will complete the first random allocation using a sealed opaque envelope. Following this a minimisation randomisation procedure will be completed based on lung function, where FEV1 of \<70% predicted lung function will be classified as having mild lung disease. While those with an FEV1 of 30-50% predicted lung function will be classified as having moderate lung disease, with \<30% indicating severe lung disease. Allocation will be revealed after recruitment and baseline assessments have occurred.

Both groups will receive a fitness tracker which will be linked to an online monitoring system (Fitabase) for 24 weeks.

The intervention group will receive personalised feedback via a text message every week on their physical activity levels as measured by their fitness tracker and progress on attainment of their goals established at the start of the study. Feedback will be provided from their CF physiotherapists.

The comparator group will not receive any feedback on their Fitbit data. After 12 weeks both groups will be re-assessed. Thereafter, both groups will continue with the Fitbits alone for 12 weeks. Finally outcome measures including lung function, physical activity levels, aerobic capacity, quality of life, sleep quality, muscle mass and well-being will be re-assessed again at 24 weeks.

Following the intervention semi structured interviews will be conducted to qualitatively establish satisfaction with the interventions and provide insight into barriers and enablers to achieving goals and physical activity levels.The results of this study may provide valuable insights into potential interventions to optimise the health and well-being of PWCF.


Options:
A: Arm Label: Standard Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Home monitoring; Type: ACTIVE_COMPARATOR; Interventions: Device: Home lung function and symptom monitoring | Intervention Type: DEVICE; Name: Home lung function and symptom monitoring; Assigned to Arm(s): Home monitoring
B: Arm Label: TEZ/IVA; Type: ACTIVE_COMPARATOR; Interventions: Drug: TEZ/IVA, Drug: IVA, Drug: Placebo | Arm Label: VX-445/TEZ/IVA TC; Type: EXPERIMENTAL; Interventions: Drug: VX-445/TEZ/IVA, Drug: IVA, Drug: Placebo | Intervention Type: DRUG; Name: VX-445/TEZ/IVA; Assigned to Arm(s): VX-445/TEZ/IVA TC | Intervention Type: DRUG; Name: TEZ/IVA; Assigned to Arm(s): TEZ/IVA | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): TEZ/IVA, VX-445/TEZ/IVA TC | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): TEZ/IVA | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): VX-445/TEZ/IVA TC
C: Arm Label: Placebo (pooled two times a day [BID]/three times a day [TID]); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo two times a day (BID)/three times a day (TID) | Arm Label: AZLI (pooled two times a day [BID]/three times a day [TID]); Type: EXPERIMENTAL; Interventions: Drug: AZLI 75 mg two times a day (BID)/three times a day (TID) | Intervention Type: DRUG; Name: AZLI 75 mg two times a day (BID)/three times a day (TID); Assigned to Arm(s): AZLI (pooled two times a day [BID]/three times a day [TID]) | Intervention Type: DRUG; Name: Placebo two times a day (BID)/three times a day (TID); Assigned to Arm(s): Placebo (pooled two times a day [BID]/three times a day [TID])
D: Arm Label: Fitbit plus personalised text messaging & Goal Setting; Type: EXPERIMENTAL; Interventions: Other: Fitness tracker with goal setting and text message feedback | Arm Label: Fitbit Only; Type: ACTIVE_COMPARATOR; Interventions: Other: Fitness Tracker only | Intervention Type: OTHER; Name: Fitness tracker with goal setting and text message feedback; Assigned to Arm(s): Fitbit plus personalised text messaging & Goal Setting | Intervention Type: OTHER; Name: Fitness Tracker only; Assigned to Arm(s): Fitbit Only

Answer: D