Clinical Trials Directory

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CompletedNCT04536012

Gamification-Augmented Home-Based Exercise for Peripheral Artery Disease

Gamification-Augmented Home-Based Exercise for Peripheral Artery Disease (GAMEPAD)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
103 (actual)
Sponsor
University of Pennsylvania · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

A randomized trial of a gamification-enhanced home-based walking program compared with a standard home-based walking program in patients with intermittent claudication. Patients will be provided with a Fitbit device and set an exercise goal. Over the next 16 weeks, patients will receive text message reminders to exercise and daily steps will be tracked. Half of patients will be randomized to a gamified interface that leverages behavioral economic principles to encourage exercise.

Detailed description

Peripheral artery disease, atherosclerotic vascular disease involving the lower extremities, leads to functional limitation by causing leg pain with ambulation (intermittent claudication). Supervised exercise programs improve walking endurance in patients with intermittent claudication, but many patients are unable to travel to centers for treatment. In a recent trial, a home-based exercise program using wearable fitness trackers and telephone coaching failed to increase walking distance in patients with intermittent claudication, but this intervention did not leverage gamification or health behavior theory. Therefore, a randomized controlled trial was proposed comparing a gamification-enhanced home-based walking program with an attention control in patients with intermittent claudication. Patients in both arms will be provided with a wearable fitness tracker, wear the tracker for 2 weeks to establish a baseline daily step count and set a goal for step increase by the end of the 16-week study period. Patients in the attention control arm will receive daily text messages with a report of their previous day's step count. Patients in the gamification intervention arm will receive automated coaching via daily text messages and the intervention will also involve a precommittment pledge, slow ramp-up of step goals, weekly progression (or regression) through levels with loss-framing of points, and support from a family member or friend. After 16 weeks, change in daily step counts from baseline will be compared between study arms. Secondary behavioral phenotyping analyses will be undertaken to identify psychometric features associated with response to the gamification intervention.

Conditions

Interventions

TypeNameDescription
BEHAVIORALGamification and Social IncentivesParticipants in the intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail.

Timeline

Start date
2020-10-05
Primary completion
2023-11-14
Completion
2024-01-08
First posted
2020-09-02
Last updated
2025-02-04
Results posted
2025-02-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04536012. Inclusion in this directory is not an endorsement.