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Steps Ahead: Optimising Physical Activity and Health in Adults With Cystic Fibrosis Using Fitness Trackers and Personalised Goal-based Text Messaging Support

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ClinicalTrials.gov Identifier: NCT03672058
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
RoisinCahalan, University of Limerick

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 Group A or Group B using computer generated randomisation. Both groups will receive a fitness tracker which will be linked to an online monitoring system (Fitabase) for 24 weeks.

Group A will not receive feedback on their activity levels. Group B 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. After 12 weeks both groups will be re-assessed. Thereafter, both groups will continue with the Fitbits alone for 12 weeks. Finally baseline 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 Behavioral: Fitness tracker with goal setting and text message feedback Behavioral: Fitness Tracker only Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Steps Ahead: Optimising Physical Activity and Health in Adults With Cystic Fibrosis Using Fitness Trackers and Personalised Goal-based Text Messaging Support
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020


Arm Intervention/treatment
Experimental: Fitbit plus text messaging & Goal Setting Behavioral: 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 Behavioral: 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




Primary Outcome Measures :
  1. Change in forced expiratory volume in 1 second (FEV1) (%predicted) [ Time Frame: Baseline to 3 months and Baseline to 6 months ]
    Spirometry

  2. Change in number of steps per day [ Time Frame: Baseline to 3 months and Baseline to 6 months ]
    Fitbit/Activpal


Secondary Outcome Measures :
  1. Change in peak oxygen uptake (% predicted) [ Time Frame: Baseline to 3 months and Baseline to 6 months ]
    Cardiopulmonary Exercise Testing

  2. Change in maximal aerobic power (%predicted) [ Time Frame: Baseline to 3 months and Baseline to 6 months ]
    Cardiopulmonary Exercise Testing

  3. Change in forced expiratory volume (FVC) (%predicted) [ Time Frame: Baseline to 3 months and Baseline to 6 months ]
    Spirometry

  4. Change in grip strength [ Time Frame: Baseline to 3 months and Baseline to 6 months ]
    Hand Dynamometry

  5. Change in body mass index (kg/m2) [ Time Frame: Baseline to 3 months and Baseline to 6 months ]
    SECA Medical Body Composition Analyser

  6. Change in muscle mass (kg) [ Time Frame: Baseline to 3 months and Baseline to 6 months ]
    SECA Medical Body Composition Analyser

  7. Change in percent body fat [ Time Frame: Baseline to 3 months and Baseline to 6 months ]
    SECA Medical Body Composition Analyser

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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


Other Outcome Measures:
  1. Time to exacerbation [ Time Frame: Baseline to 3 months and Baseline to 6 months ]
  2. Semi Structured Interviews [ Time Frame: At 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

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


Contacts
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Contact: Roisin Cahalan, PhD +353 61 202959 ext +35361202959 roisin.cahalan@ul.ie
Contact: Maire Curran, BSc +353 61 482151 ext +35361202959 maire.curran@ul.ie

Locations
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Ireland
University Hospital Limerick Recruiting
Limerick, Ireland
Sponsors and Collaborators
University of Limerick
Investigators
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Principal Investigator: Roisin Cahalan, PhD University of Limerick
Principal Investigator: Audrey Tierney, PhD University of Limerick

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Responsible Party: RoisinCahalan, Lecturer Physiotherapy, University of Limerick
ClinicalTrials.gov Identifier: NCT03672058     History of Changes
Other Study ID Numbers: CF UHL UL
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RoisinCahalan, University of Limerick:
Cystic Fibrosis, CF
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases