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

NCT ID: NCT07043127

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Total Hip Arthroplasty (THA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Control Group

Regular Rehabilitation Training

Group Type: ACTIVE_COMPARATOR

Sham-BFR

Intervention Type: 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.

Intervention Group

BFR-Intervention during Rehabilitation Training

Group Type: EXPERIMENTAL

BFR

Intervention Type: 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.

Interventions

Sham-BFR

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.

Intervention Type: OTHER

BFR

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

Alexander Franz

Dr. med., B.Sc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Bonn

Bonn, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

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

Role: CONTACT

alexander.franz@ukbonn.de

+491703750718

Facility Contacts

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

Role: primary

alexander.franz@ukbonn.de

+491703750718

Role: backup

alexander.franz@ukbonn.de

Other Identifiers

2024_E

Identifier Type: -

Identifier Source: org_study_id