Clinical trial NCT03672058: Steps Ahead: Optimising Physical Activity and Health in Adults With Cystic Fibrosis
Official title: Steps Ahead: Optimising Physical Activity and Health in Adults With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis, CF
Lead sponsor: University of Limerick
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in forced expiratory volume in 1 second (FEV1) (%predicted)
timeFrame: Baseline to 3 months and Baseline to 6 months
measure: Change in peak oxygen uptake (% predicted)
timeFrame: Baseline to 3 months and Baseline to 6 months
measure: Change in number of steps per day
timeFrame: Baseline to 3 months and Baseline to 6 months
Secondary outcomes:
measure: Change in maximal aerobic power (%predicted)
timeFrame: Baseline to 3 months and Baseline to 6 months
measure: Change in forced expiratory volume (FVC) (%predicted)
timeFrame: Baseline to 3 months and Baseline to 6 months
measure: Change in grip strength
timeFrame: Baseline to 3 months and Baseline to 6 months
measure: Change in body mass index (kg/m2)
timeFrame: Baseline to 3 months and Baseline to 6 months
measure: Change in muscle mass (kg)
timeFrame: Baseline to 3 months and Baseline to 6 months
measure: Change in percent body fat
timeFrame: Baseline to 3 months and Baseline to 6 months
measure: Change in Cystic Fibrosis Quality of Life Scale (CFQR)
timeFrame: Baseline to 3 months and Baseline to 6 months
measure: Change in self reported physical activity (International Physical Activity Questionnaire Short Form)
timeFrame: Baseline to 3 months and Baseline to 6 months
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline to 3 months and Baseline to 6 months
measure: The University of California San Diego (UCSD) Shortness of Breath Questionnaire
timeFrame: Baseline to 3 months and Baseline to 6 months
measure: Change in wellbeing
timeFrame: Baseline to 3 months and Baseline to 6 months
measure: Change in number of minutes spent in moderate to vigorous physical activity (MVPA)
timeFrame: Baseline to 3 months and Baseline to 6 months
Other outcomes:
measure: Time to exacerbation
timeFrame: Baseline to 3 months and Baseline to 6 months
measure: Semi Structured Interviews
timeFrame: At 6 months
Locations:
city: Limerick
country: Ireland
facility: University Hospital Limerick
Study officials:
affiliation: University of Limerick
name: Roisin Cahalan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Limerick
name: Audrey Tierney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.