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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
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sarcoidosis focused on measuring Physical Activity, Exercise Capacity, Activity Tracker

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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

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    Benefit of Wearing an Activity Tracker in Sarcoidosis

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