Benefit of Wearing an Activity Tracker in Sarcoidosis

NCT04475653 | Completed

• 1 other identifier: ildcarefitbit2017
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sarcoidosis; Fatigue

Keywords

Physical Activity; Exercise Capacity; Activity Tracker

Outcome Measures

Primary Outcomes (3)

• 6 Minute Walking Distance (MWD)

  Change from baseline in 6 MWD in 3 months

  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.

  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

  3 months

Secondary Outcomes (1)

• Lung function tests

  3 months

Study Arms (3)

Group coaching

ACTIVE COMPARATOR

Performing physical activities with Activity tracker, coaching included

Behavioral: Physical Activity using an Activity Tracker

Group Independant

ACTIVE COMPARATOR

Performing physical activities with Activity tracker, coaching NOT included

Behavioral: Physical Activity using an Activity Tracker

Controls

OTHER

Controls from former study (see Study description)

Behavioral: Physical Activity using an Activity Tracker

Interventions

Physical Activity using an Activity Tracker BEHAVIORAL

Controls; Group Independant; Group coaching

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• ild care foundation: collaborator
• St. Antonius Hospital: collaborator
• Gelderse Vallei Hospital: collaborator

Related Links

• Related Info

MeSH Terms

Conditions

Sarcoidosis; Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Marjolein Drent, MD, PhD

  ild care foundation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 17, 2020
• Study Start: July 8, 2016
• Primary Completion: November 11, 2017
• Study Completion: December 18, 2017
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share