Steps Ahead: Optimising Physical Activity and Health in Adults With Cystic Fibrosis

NCT ID: NCT03672058

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2020-06-28

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fitbit plus personalised text messaging & Goal Setting

Group Type: EXPERIMENTAL

Fitness tracker with goal setting and text message feedback

Intervention Type: OTHER

Participants provided with a Fitbit and this will also be linked to Fitabase. The physiotherapist will discuss the participants' baseline physical activity levels and individual patient centred short and long-term goals will be set with each participant. Every week participants will be contacted via text message by their CF physiotherapist. The physiotherapist will review their online data and will provide feedback and encouragement on their progress. Goals will be reviewed for each participant.

Fitbit Only

Group Type: ACTIVE_COMPARATOR

Fitness Tracker only

Intervention Type: OTHER

Participants will be provided with the Fitbit and educated on how to use it. This will be linked to "Fitabase", an online monitoring system for data collection purposes, with the consent of the participants. However no goal setting will be completed and no feedback will be provided to the participants on their physical activity levels

Interventions

Fitness tracker with goal setting and text message feedback

Participants provided with a Fitbit and this will also be linked to Fitabase. The physiotherapist will discuss the participants' baseline physical activity levels and individual patient centred short and long-term goals will be set with each participant. Every week participants will be contacted via text message by their CF physiotherapist. The physiotherapist will review their online data and will provide feedback and encouragement on their progress. Goals will be reviewed for each participant.

Intervention Type: OTHER

Fitness Tracker only

Participants will be provided with the Fitbit and educated on how to use it. This will be linked to "Fitabase", an online monitoring system for data collection purposes, with the consent of the participants. However no goal setting will be completed and no feedback will be provided to the participants on their physical activity levels

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Clinically stable CF patients
• Age > 18 years
• Confirmed diagnosis of CF
• Access to a smartphone/tablet to access and upload to Fitbit Application.
• Capacity and willingness to give explicit informed consent

Exclusion Criteria

• FEV1 < 25%.
• Patients on the waiting list for lung transplantation and those who have undergone lung transplantation.
• Patients with an exacerbation in the four weeks prior to the study. For the purpose of this study pulmonary exacerbation will be defined as acute or subacute worsening of respiratory symptoms which warrant change in treatment (i.e., new oral or intravenous antibiotics). Patients can undergo testing once they are finished their antibiotics and deemed clinically stable.
• Patients dependent on supplemental oxygen for exercise.
• Pregnancy
• Participation in another clinical trial up to 4 weeks prior to the first baseline visit

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Limerick

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roisin Cahalan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Limerick

Audrey Tierney, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Limerick

Locations

University Hospital Limerick

Limerick, , Ireland

Countries

Ireland

References

Curran M, Tierney AC, Collins L, Kennedy L, McDonnell C, Jurascheck AJ, Sheikhi A, Walsh C, Button B, Galvin R, Casserly B, Cahalan R. Steps Ahead: optimising physical activity in adults with cystic fibrosis: Study Protocol for a pilot randomised trial using wearable technology, goal setting and text message feedback. HRB Open Res. 2020 Nov 16;3:21. doi: 10.12688/hrbopenres.13025.3. eCollection 2020.

Reference Type: DERIVED

PMID: 33283151 (View on PubMed)

Other Identifiers

CF UHL UL

Identifier Type: -

Identifier Source: org_study_id