Benefit of Wearing an Activity Tracker in Sarcoidosis (ildfitbit)
Primary Purpose
Sarcoidosis, Fatigue
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical Activity using an Activity Tracker
Sponsored by
About this trial
This is an interventional supportive care trial for Sarcoidosis focused on measuring Physical Activity, Exercise Capacity, Activity Tracker
Eligibility Criteria
Inclusion Criteria:
- participants being in a clinically stable condition
- no change in initiated medical management during the preceding three months
- having sufficient command of the Dutch language
- having internet access at home or a compatible smartphone/tablet.
Exclusion Criteria:
- Patients participated in a training program during the six months prior to inclusion were excluded.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Other
Arm Label
Group coaching
Group Independant
Controls
Arm Description
Performing physical activities with Activity tracker, coaching included
Performing physical activities with Activity tracker, coaching NOT included
Controls from former study (see Study description)
Outcomes
Primary Outcome Measures
6 Minute Walking Distance (MWD)
Change from baseline in 6 MWD in 3 months
Fatigue monitoring
Fatigue was measured with the 10-item Fatigue Assessment Scale (FAS) [9]. This questionnaire was filled out on a weekly basis. Outcome measure: Change from baseline in fatigue during 3 months.
FAS scores 10 - 21: no fatigue (normal) FAS scores 22 - 50: substantial fatigue
Subscores:
fatigue: scores 22-34
extreme fatigue: scores ≥ 35
The Minimal Important Difference (MCID) is at least 4 points or 10% change of the baseline value.
Steep ramp test (SRT)
Exercise performance protocol on a cycle ergometer. Outcome: Change from baseline and after 3 months intervention of physical activity
Secondary Outcome Measures
Lung function tests
Forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) were measured with a pneumotachograph. The diffusing capacity of the lung for carbon monoxide (DLCO) was measured using the single-breath method (Masterlab, Jaeger, Würzburg, Germany). Values were expressed as a percentage of the predicted value (i.e., FVC%, FEV1%, and DLCO% respectively).
Outcome measure: Change baseline and after 3 months intervention
Full Information
NCT ID
NCT04475653
First Posted
July 1, 2020
Last Updated
July 14, 2020
Sponsor
Maastricht University Medical Center
Collaborators
ild care foundation, St. Antonius Hospital, Gelderse Vallei Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04475653
Brief Title
Benefit of Wearing an Activity Tracker in Sarcoidosis
Acronym
ildfitbit
Official Title
Benefit of Wearing an Activity Tracker in Sarcoidosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 8, 2016 (Actual)
Primary Completion Date
November 11, 2017 (Actual)
Study Completion Date
December 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
ild care foundation, St. Antonius Hospital, Gelderse Vallei Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Sarcoidosis causes many disabling symptoms, including fatigue, muscle weakness, and exercise limitations. Physical activity programs have been shown to improve physical performance and decrease fatigue in sarcoidosis.
Objectives: The aim of this study was to evaluate (1) the effect of continuous activity monitoring using an electronic activity tracker (AT), compared to controls, and (2) the effect of additional personal coaching on exercise performance and fatigue of sarcoidosis patients.
Method: This prospective, randomized clinical trial included 54 sarcoidosis patients who received an AT (Group Ia: 27 with coaching and Group Ib: 27 without). Exercise capacity and fatigue scores (Fatigue Assessment Scale) were evaluated at baseline and after three months. A historical group of sarcoidosis patients (Group II; n=41) from an earlier study who did not follow a physical activity program served as controls.
Detailed Description
Sarcoidosis patients often suffer not only from organ-related symptoms but also from disabling non-specific, non-organ-related symptoms, such as fatigue, reduced muscle strength, loss of physical condition, reduction of physical activity (PA) in daily life and pain. Fatigue is the most frequently reported in sarcoidosis patients disregarding the clinical presentation, varying from 50 to 90%. This may persist after other signs of sarcoidosis activity have resolved, and adversely impacts major life areas, including quality of life (QoL) and work ability.
So far, there is promising evidence for the benefits of physical training in sarcoidosis. Interventions involving technology that is readily accessible on a daily basis to monitor activity levels can support care providers in encouraging patients to achieve behavioral changes. These interventions may be an effective strategy to provide PA-coaching without increasing time demands on primary care providers. Moreover, they give patients an opportunity to keep up a more active lifestyle with direct feedback and monitor their physical performance over time. Counseling, guidance and support using e-health technology had been found to be very helpful for patients who want to improve their PA. The use of commercially available, technology-based wearable activity trackers (ATs) such as Fitbit is growing for research and recreational purposes, both among healthy persons and among those with chronic illness. Beneficial effects of AT-based counseling have been demonstrated in patients with chronic diseases. In a recent study by our group we found that wearing an AT stimulated patients to be more physically active.
The aim of this study was to evaluate (1) the effect of continuous activity monitoring using an electronical AT and (2) the effect of additional personal coaching of sarcoidosis patients. The outcome measures were exercise performance and fatigue.
Intervention All participants received a Fitbit for free. They were encouraged to improve their physical fitness, which was assessed at baseline. The patients in the intervention group (group Ia) engaged in a three-month physical therapist-guided activity program. The guidance was based on the input from the AT and the questionnaires. The weekly FAS scores, Fitbit-measured parameters and brief daily questions were combined in a web-based dashboard accessible to the assigned physical therapist. The information was used for goal setting, encouraging, and identifying barriers and facilitators for patients becoming more active. The coaching procedure included weekly action planning and feedback, modelling of behaviors and problem solving, and individual decision making by email and/or telephone. The coaching physical therapist acted as facilitator, and assisted participants in making choices and achieving success in terms of reaching self-selected goals.
Although the patients in group Ib did not receive the guidance from a physical therapist, their daily activity was also computed with the Fitbit Charge HR (Brand name), and patients were also able to use a Fitbit and monitor app to monitor their performance, questionnaire results and progress.
Self-report feedback questionnaires at follow-up (12 weeks) were used to determine participants' experience with data from the Fitbit tracker itself and coaching, if applicable.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis, Fatigue
Keywords
Physical Activity, Exercise Capacity, Activity Tracker
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This prospective, randomized clinical trial included 54 sarcoidosis patients who received an AT (Group Ia: 27 with coaching and Group Ib: 27 without). Exercise capacity and fatigue scores (Fatigue Assessment Scale) were evaluated at baseline and after three months. A historical group of sarcoidosis patients (Group II; n=41) from an earlier study who did not follow a physical activity program served as controls.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group coaching
Arm Type
Active Comparator
Arm Description
Performing physical activities with Activity tracker, coaching included
Arm Title
Group Independant
Arm Type
Active Comparator
Arm Description
Performing physical activities with Activity tracker, coaching NOT included
Arm Title
Controls
Arm Type
Other
Arm Description
Controls from former study (see Study description)
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity using an Activity Tracker
Primary Outcome Measure Information:
Title
6 Minute Walking Distance (MWD)
Description
Change from baseline in 6 MWD in 3 months
Time Frame
3 months
Title
Fatigue monitoring
Description
Fatigue was measured with the 10-item Fatigue Assessment Scale (FAS) [9]. This questionnaire was filled out on a weekly basis. Outcome measure: Change from baseline in fatigue during 3 months.
FAS scores 10 - 21: no fatigue (normal) FAS scores 22 - 50: substantial fatigue
Subscores:
fatigue: scores 22-34
extreme fatigue: scores ≥ 35
The Minimal Important Difference (MCID) is at least 4 points or 10% change of the baseline value.
Time Frame
3 months
Title
Steep ramp test (SRT)
Description
Exercise performance protocol on a cycle ergometer. Outcome: Change from baseline and after 3 months intervention of physical activity
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Lung function tests
Description
Forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) were measured with a pneumotachograph. The diffusing capacity of the lung for carbon monoxide (DLCO) was measured using the single-breath method (Masterlab, Jaeger, Würzburg, Germany). Values were expressed as a percentage of the predicted value (i.e., FVC%, FEV1%, and DLCO% respectively).
Outcome measure: Change baseline and after 3 months intervention
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
participants being in a clinically stable condition
no change in initiated medical management during the preceding three months
having sufficient command of the Dutch language
having internet access at home or a compatible smartphone/tablet.
Exclusion Criteria:
- Patients participated in a training program during the six months prior to inclusion were excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjolein Drent, MD, PhD
Organizational Affiliation
ild care foundation
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.ildcare.nl/index.php/benefits-of-e-health-based-coaching-of-physical-training-in-patients-with-ild/
Description
Related Info
Learn more about this trial
Benefit of Wearing an Activity Tracker in Sarcoidosis
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