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CompletedNCT06942065Updated Apr 24, 2025

Clinical-randomized Study of the Influence of Rehabilitation Therapy Using Strength and Blood Flow Restriction Training on Muscular Fitness and Regeneration After Elective Total Knee Arthroplasty

An interventional study of Sham-BFR and Blood Flow Restriction Training in Osteoarthritis (OA) of the Knee and Muscle Atrophy, sponsored by University Hospital, Bonn. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-24.

Sponsored by University Hospital, Bonn · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Jun 2023, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The present study investigates the effects of blood flow restriction training on muscular recovery during out-patient rehabilitation after elective total knee arthroplasty

Read the detailed description

The present study evaluated the impact of blood flow restriction training in the context of three-week outpatient rehabilitation following TKA, in accordance with the guidelines of the German Pension Insurance System. The in-rehabilitation and post-rehabilitation muscle status, strength, knee functionality, impairments in daily life and subjective pain perception were measured.

02

Conditions studied

  • Osteoarthritis (OA) of the Knee
  • Muscle Atrophy

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03

In context

Muscular Atrophy

494 studies on the registry are indexed under Muscular Atrophy; 94 are open to participants now.

This study's enrollment of 25 is below the median of 33 across 335 interventional studies indexed under Muscular Atrophy.

Browse Muscular Atrophy studies →

Lead sponsor

University Hospital, Bonn is the lead sponsor of 154 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Physical Fitness for Rehabilitation
  • Primary TKA surgery
  • BMI \< 35

Exclusion criteria

Exclusion Criteria:

  • Sickle Cell Anemia
  • Vascular Intervention on the lower extremities
  • Open Wounds
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • Sham comparator
    Control Group

    Control sham condition which performed the exercise with a fixed pressure of 20mmHg

    Procedure: Sham-BFR

  • Experimental
    Blood Flow Restriction Group

    This intervention groups performed training on the operated limb with a BFR pressure corresponding to 60% of the individual limb occlusion pressure

    Procedure: Blood Flow Restriction Training

Interventions

  • ProcedureSham-BFR

    The exercise protocol for the operated leg (with sham pressure of 20mmHg) consisted of four sets with 75 repetitions (reps) in total (1. Set: 30 reps, 2.-4. Set: 15 reps) with 30% of the individual one-repetition maximum for each exercise and were performed five times per week during the three-week outpatient rehabilitation.

  • ProcedureBlood Flow Restriction Training

    The exercise protocol for the operated leg (with a BFR pressure of 60% of the LOP) consisted of four sets with 75 repetitions (reps) in total (1. Set: 30 reps, 2.-4. Set: 15 reps) with 30% of the individual one-repetition maximum for each exercise and were performed five times per week during the three-week outpatient rehabilitation.

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What researchers measure

Primary outcomes

  1. Postoperative Pain

    Postoperative Pain was assessed by visual analoge scale (0-100mm)

    Time frame: Pre- to 6 weeks Post Rehabilitation

  2. Muscle Strength

    Isometric muscle strength was measured on a DDRobotec (Dynamic Devices AG, Zurich, Switzerland), a pneumatic, computer-controlled leg press

    Time frame: Pre- to 6 weeks Post Rehabilitation

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Study locations

1 site
  • University Hospital Bonn
    Bonn, NRW 53127, Germany
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06942065
Lead sponsor
University Hospital, Bonn
Responsible party
Alexander Franz (Dr. med., B.Sc., University Hospital, Bonn) — Principal investigator
First posted
Apr 24, 2025
Start date
Jun 1, 2023
Primary completion
Dec 31, 2024
Completion
Jan 1, 2025
Last update
Apr 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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