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FitBit coaching may help amputees walk more after surgery

NCT ID NCT04083456

Symptom relief Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study tests whether a walking program that uses FitBit tracking and personalized coaching can help people who recently had a leg amputation due to diabetes or peripheral artery disease become more physically active. Participants will use a FitBit to monitor their steps and receive feedback and support to overcome barriers to walking. The goal is to see if this approach improves their daily step count and confidence in managing their health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Walking biobehavioral intervention using FitBit self-monitoring and coaching
What this could lead to
If effective, this program could become a standard rehabilitation approach to help amputees with diabetes or peripheral artery disease improve their physical activity and overall health.
What could go wrong
This is a small early-stage study, so results may not apply to all amputees. The program requires active participation, and some may find it difficult to maintain walking goals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

35 people

The number who actually took part.

Started

Nov 2019

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Within the age range of 50-85 years * Confirmed diagnosis of Type II Diabetes Mellitus (DM) and/or Peripheral Artery Disease (PAD) * Transtibial, knee disarticulation, or transfemoral lower-limb amputation (LLA) (or re-amputation) within the past 12 months * Participant goal of household walking or better using a prosthesis Exclusion Criteria: * Trauma or cancer-related etiology of the LLA * Decisionally challenged individuals (MMSE score below 24) * Prisoners * Active cancer treatment * Recent stroke (within 2 years) * Clinical discretion of principal investigator to exclude patients who are determined to be unsafe and/or inappropriate to participate in the described intervention.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Motor Activity peripheral arterial disease type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amputation Diabetes mellitus Peripheral artery disease

Contacts and locations

Locations

  • University of Colorado Hospital

    Aurora, Colorado, 80045, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.