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NCT Number: NCT07043127

Impact of Rehabilitation Therapy Using Strength and Blood Flow Restriction Training on Muscular Fitness and Regeneration After Elective Hip Replacement

In the present project, the framework conditions of outpatient rehabilitation at the Bonn Center for Outpatient Rehabilitation will now be used to prove whether sports science-controlled strength and BFR training has a similar effect in the postoperative rehabilitation phase. Strength and BFR training in medical training therapy complements daily exercise therapy in order to ensure implementation in the guideline-based rehabilitation process. . The interventions are carried out as part of the exercise therapy units in outpatient rehabilitation ETM01 following the RTS hip and knee TEP basis KTL 2020.

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Key information

Conditions

Total Hip Arthroplasty (THA)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location status: Recruiting

Location contact

Alexander Franz, Dr. med., B.Sc.

CONTACT

[email protected]

+491703750718

Alexander Franz, Dr. med., B.Sc.

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability for Rehabilitation
  • Total Hip Arthroplasty Surgery during the last 4 Weeks

Exclusion criteria

  • Sickle Cell Anemia
  • Iatrogenic changes in the vessels of the lower Extremity (e.g. Stents)
  • Open Wounds or Infections of the lower Extremity

Treatment and study plan

Sham-BFR

Other

The exercise protocol provides for units of approx. 25 minutes of BFR training five times a week as part of medical training therapy. Based on the initial strength measurements prior to rehabilitation, the training phase of the intervention group starts with 30% of the 1RM (calculated from the force-velocity profile) and 70% LOP in the operated leg and 75% of the 1RM (calculated from the force-velocity profile) in the unoperated leg. The patients are randomized into 2 groups: 1) intervention group, which receives a daily intervention with an occlusion pressure and the 2) control group, which receives a daily "Sham-BFR" intervention with an occlusion pressure of 20mmHg.

BFR

Other

The exercise protocol provides for units of approx. 25 minutes of BFR training five times a week as part of medical training therapy. Based on the initial strength measurements prior to rehabilitation, the training phase of the intervention group starts with 30% of the 1RM (calculated from the force-velocity profile) and 70% LOP in the operated leg and 75% of the 1RM (calculated from the force-velocity profile) in the unoperated leg. The patients are randomized into 2 groups: 1) intervention group, which receives a daily intervention with an occlusion pressure and the 2) control group, which receives a daily "Sham-BFR" intervention with an occlusion pressure of 20mmHg.

Primary outcomes

  1. Muscle Strength

    Time frame: Pre- (Baseline) to Post-Rehabilitation (after three weeks of outpatient rehabilitation)

    Muscle Strength will be assessed by isometric maximal contraction test on a leg press machine

  2. Subjective Pain Level

    Time frame: Pre- (Baseline) to Post-Rehabilitation (after three weeks of outpatient rehabilitation)

    Visual analog scale (0-100mm)

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Franz, Dr. med., B.Sc.

CONTACT

[email protected]

+491703750718

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Official study title

Clinical Randomized Trial of the Influence of Rehabilitation Therapy Using Strength and Blood Flow Restriction Training on Muscular Fitness and Regeneration After Elective Hip Replacement

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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