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

NCT07043127 | Recruiting

• 1 other identifier: 2024_E
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (2)

• Muscle Strength

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

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

• Subjective Pain Level

  Visual analog scale (0-100mm)

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

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Regular Rehabilitation Training

Other: Sham-BFR

Intervention Group

EXPERIMENTAL

BFR-Intervention during Rehabilitation Training

Other: BFR

Interventions

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.

Control Group

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Central Study Contacts

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

CONTACT

+491703750718; alexander.franz@ukbonn.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med., B.Sc.

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 29, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)