Steps Ahead: Optimising Physical Activity and Health in Adults With Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT03672058|
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : March 26, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Other: Fitness tracker with goal setting and text message feedback Other: Fitness Tracker only||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Steps Ahead: Optimising Physical Activity and Health in Adults With Cystic Fibrosis|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||June 28, 2020|
|Estimated Study Completion Date :||June 28, 2020|
|Experimental: Fitbit plus personalised text messaging & Goal Setting||
Other: 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.
|Active Comparator: Fitbit Only||
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
- Change in forced expiratory volume in 1 second (FEV1) (%predicted) [ Time Frame: Baseline to 3 months and Baseline to 6 months ]Spirometry
- Change in peak oxygen uptake (% predicted) [ Time Frame: Baseline to 3 months and Baseline to 6 months ]Cardiopulmonary Exercise Testing
- Change in number of steps per day [ Time Frame: Baseline to 3 months and Baseline to 6 months ]Fitbit/Activpal
- Change in maximal aerobic power (%predicted) [ Time Frame: Baseline to 3 months and Baseline to 6 months ]Cardiopulmonary Exercise Testing
- Change in forced expiratory volume (FVC) (%predicted) [ Time Frame: Baseline to 3 months and Baseline to 6 months ]Spirometry
- Change in grip strength [ Time Frame: Baseline to 3 months and Baseline to 6 months ]Hand Dynamometry
- Change in body mass index (kg/m2) [ Time Frame: Baseline to 3 months and Baseline to 6 months ]SECA Medical Body Composition Analyser
- Change in muscle mass (kg) [ Time Frame: Baseline to 3 months and Baseline to 6 months ]SECA Medical Body Composition Analyser
- Change in percent body fat [ Time Frame: Baseline to 3 months and Baseline to 6 months ]SECA Medical Body Composition Analyser
- Change in Cystic Fibrosis Quality of Life Scale (CFQR) [ Time Frame: Baseline to 3 months and Baseline to 6 months ]Measurement of the quality of life by the Cystic Fibrosis Questionnaire Revised (CFQ-R, Quality of life domains: Physical, role/school, vitality, emotion, social, body image, eating, treatment burden, health perceptions. Symptom scales: Weight, respiratory, and digestion). There are 5 distinct 4-point Likert scale. Scores range from 0 to 100, with higher scores indicating better health.
- Change in self reported physical activity (International Physical Activity Questionnaire Short Form) [ Time Frame: Baseline to 3 months and Baseline to 6 months ]International Physical Activity Questionnaire. This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. It assesses 7 items to get a global score and then categorizes physical activity into low, moderate or high.
- Pittsburgh Sleep Quality Index [ Time Frame: Baseline to 3 months and Baseline to 6 months ]The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
- The University of California San Diego (UCSD) Shortness of Breath Questionnaire [ Time Frame: Baseline to 3 months and Baseline to 6 months ]To assess dyspnea associated with activities of daily living (ADLs). There are 24 items on this questionnaire. Each item is assessed on a 6-point scale (0 = "not at all" to 5 = "maximal or unable to do because of breathlessness"). Scores range from 0 to 120 with higher scores indicating activities of daily living are extremely limited by shortness of breath.
- Change in wellbeing [ Time Frame: Baseline to 3 months and Baseline to 6 months ]Alfred Wellness Score. This questionnaire assesses state of wellness to assist in providing best health care. There are 10 questions which are scored from 0-10. 10 reflects most well state of being possible while zero reflects least well state. Scores range from 0-100 with higher scores indicating good state of wellness.
- Change in number of minutes spent in moderate to vigorous physical activity (MVPA) [ Time Frame: Baseline to 3 months and Baseline to 6 months ]Fitbit/Activpal
- Time to exacerbation [ Time Frame: Baseline to 3 months and Baseline to 6 months ]
- Semi Structured Interviews [ Time Frame: At 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672058
|Contact: Roisin Cahalan, PhD||+353 61 202959 ext +email@example.com|
|Contact: Maire Curran, BSc||+353 61 482151 ext +firstname.lastname@example.org|
|University Hospital Limerick||Recruiting|
|Principal Investigator:||Roisin Cahalan, PhD||University of Limerick|
|Principal Investigator:||Audrey Tierney, PhD||University of Limerick|