SarcoidosisildfitbitNCT04475653
Benefit of Wearing an Activity Tracker in Sarcoidosis
A study testing Physical Activity using an Activity Tracker in people with Sarcoidosis and Fatigue, run by Maastricht University Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sarcoidosis, Fatigue
- What is being tested?
- Physical Activity using an Activity Tracker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 8 Jul 2016to 18 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients participated in a training program during the six months prior to inclusion were excluded.
About this study
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.
Read the 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.
- Conditions
- Sarcoidosis, Fatigue
- Being tested
- Physical Activity using an Activity Tracker
- Keywords
- Physical Activity, Exercise Capacity, Activity Tracker
- Medical subject headings
- Sarcoidosis, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity using an Activity TrackerBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Group coaching | Active comparator | Performing physical activities with Activity tracker, coaching included Receives: Behavioral: Physical Activity using an Activity Tracker |
| Group Independant | Active comparator | Performing physical activities with Activity tracker, coaching NOT included Receives: Behavioral: Physical Activity using an Activity Tracker |
| Controls | Other | Controls from former study (see Study description) Receives: Behavioral: Physical Activity using an Activity Tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walking Distance (MWD)
Change from baseline in 6 MWD in 3 months
Measured: 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.
Measured: 3 months
Steep ramp test (SRT)
Exercise performance protocol on a cycle ergometer. Outcome: Change from baseline and after 3 months intervention of physical activity
Measured: 3 months
Secondary outcomes (1)
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start8 Jul 2016
- Primary completion11 Nov 2017
- Study completion18 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ild care foundation, St. Antonius Hospital, Gelderse Vallei Hospital
- Responsible party
- Sponsor
- Investigators
- Marjolein Drent, MD, PhD, Study chair, ild care foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475653
- Sponsor's protocol ID
- ildcarefitbit2017
- Acronym
- ildfitbit
- Status last verified
- Jul 2020
- First submitted
- 1 Jul 2020
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Wearing an Activity Tracker in Sarcoidosis
- ClinicalTrials.gov ID
- NCT04475653
- Acronym / sponsor ID
- ildfitbit / ildcarefitbit2017
- Conditions
- Sarcoidosis, Fatigue
- Keywords
- Physical Activity, Exercise Capacity, Activity Tracker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ild care foundation, St. Antonius Hospital, Gelderse Vallei Hospital
- Study start
- 8 Jul 2016 (actual)
- Primary completion
- 11 Nov 2017 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group coaching | Active comparator | Behavioral: Physical Activity using an Activity TrackerPerforming physical activities with Activity tracker, coaching included |
| Group Independant | Active comparator | Behavioral: Physical Activity using an Activity TrackerPerforming physical activities with Activity tracker, coaching NOT included |
| Controls | Other | Behavioral: Physical Activity using an Activity TrackerControls from former study (see Study description) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients participated in a training program during the six months prior to inclusion were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity using an Activity Tracker | Behavioural | Controls, Group Independant, Group coaching |
Primary outcome
6 Minute Walking Distance (MWD)
Time frame: 3 months
Change from baseline in 6 MWD in 3 months
Fatigue monitoring
Time frame: 3 months
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)
Time frame: 3 months
Exercise performance protocol on a cycle ergometer. Outcome: Change from baseline and after 3 months intervention of physical activity
1 secondary outcome
Lung function tests
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjolein Drent, MD, PhD study chair
ild care foundation
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity using an Activity Tracker in people with Sarcoidosis and Fatigue, run by Maastricht University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walking Distance (MWD) (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.