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Light exercise with a blood pressure cuff may rebuild leg muscle after knee replacement

NCT ID NCT04018638

Disease control Sponsor: Michigan Technological University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This study tests whether a home exercise program using a blood pressure cuff to partially restrict blood flow can help people regain leg muscle strength and walking ability after a total knee replacement. Participants will do light exercises three times a week for ten weeks. The goal is to see if this approach is safe and effective for overcoming the muscle weakness that often persists after surgery.

What this could mean

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

Active substance
blood-flow restriction exercise enhancement (B-FREE)
What this could lead to
If effective, B-FREE could offer a safe, home-based way to speed up muscle recovery and improve walking after knee replacement.
What could go wrong
This is a small early study with only 30 participants, so results may not apply to everyone. The technique involves partially blocking blood flow, which carries risks for people with certain health conditions.

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2019

Expected to finish

Dec 2027

An estimate. End dates often move.

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

40 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 * 40-75 years of age * Have had a unilateral TKA \> 6 months prior to participation (Arm 1) * No previous history of knee injury/surgery (Arm 2) Exclusion Criteria * Are a smoker * Have diabetes * Have suffered a heart attack or stroke * Have any cardiopulmonary disorders (hypertension discussed below) * Have been diagnosed with any neurological disorders * Have any implanted devices such as but not limited to a pacemaker or pain pump * Uncontrolled (not medicated) Stage 1 hypertension or Stage 2 hypertension

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Conditions

The condition(s) this trial relates to.

Knee Injuries osteoarthritis, knee

As listed by the trial registrant

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

Knee arthritis Knee injuries Knee osteoarthritis

Contacts and locations

Locations

  • Michigan Technological University

    Houghton, Michigan, 49931, United States

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