The Efficacy of Low-load Blood Flow Restricted Resistance Before TKR

NCT04081493 | Completed DMC

• 1 other identifier: Okklusionsprojektet
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 3

Brief Summary

The primary aim of this study is to investigate the efficacy of 8 weeks of Low-load blood flow restricted exercise (BFRE) compared to receiving standard care only (no preoperative training) before total knee replacement (TKR) on postoperative 30-seconds chair stand test (30s-CST). We hypothesize that 8 weeks of preoperative BFRE will increase chair stand performance 3 months postoperatively. Secondary aims are to investigate the efficacy of 8 weeks of preoperative BFRE compared to receiving standard care only on changes in muscle strength 3 months after TKR and investigate associations to functional capacity and quality of life. Furthermore, it will be investigated if 8 weeks of BFRE induces muscle hypertrophy and increases satellite cell and myonuclei content of the vastus lateralis muscle.

Conditions

Total Knee Replacement

Keywords

Low-load blood flow restricted exercise; Preconditioning; Functional capacity

Outcome Measures

Primary Outcomes (1)

• 30-seconds chair stand test (30-sec CST)

  The 30s-CST measures the number of sit-to-stand repetitions completed within 30 seconds. Patients will be instructed to perform a sit-to-stand movement starting from a seated position (seat height 43 cm without armrests) having the feet placed flat on the floor shoulder width apart, and arms crossed on chest to a standing position (hip and knee joints fully extended) repeated as many times as possible for 30 seconds.

  change in 30-sec CST from baseline to 3 months after surgery

Secondary Outcomes (10)

• Timed Up & Go

  Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery

• 4x10 meter fast-paced walk test (40m-FWT)

  Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery

• 1RM leg press strength

  Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery

• 1RM knee extension strength

  Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery

• Isometric knee extensor strength

  Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery

Other Outcomes (6)

• Blood pressure (used for eligibility)

  Baseline

• Exercise compliance and progression

  The exercise period (8 weeks)

• Numeric Rating Scale Pain (NRS pain)

  Baseline, during each training session, in the week of surgery, 3 months after surgery, 12 months after surgery

Study Arms (2)

Group 1 (BFRE)

EXPERIMENTAL

Low-load blood flow restricted exercise 3/weekly for 8 weeks before TKR 10-min warm-up followed by unilateral leg press and unilateral knee extension

Other: Low-load blood flow restricted exercise

Group 2 (CON)

NO INTERVENTION

No training before TKR

Interventions

Low-load blood flow restricted exercise OTHER

Leg press and knee extension exercise 3 times per week for 8 weeks. Repetition scheme: 30-15-15-until exhaustion interspaced by 30 sec rest. 5 min "free-flow" rest between exercises

Group 1 (BFRE)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 50 years scheduled for TKA at Horsens- or Silkeborg Regional Hospital.

You may not qualify if:

• Severe cardiovascular diseases (New York Heart Association class III and IIII), previous stroke incident, thrombosis incident
• Traumatic nerve injury in affected limb
• Unregulated hypertension (Systolic ≥180 or diastolic ≥110 mmHg)
• Spinal cord injury
• Pregnancy
• Planned other lower limb surgery within 12 months
• Cancer diagnosis and currently undergoing chemo-, immuno-, or radiotherapy
• Inadequacy in written and spoken Danish
• an existing prosthesis in the index limb
• living more than 45 minutes from either Horsens Regional Hospital or Silkeborg Regional Hospital.

Sponsors & Collaborators

• University of Aarhus: lead
• Horsens Hospital: collaborator
• Regionshospitalet Silkeborg: collaborator

Study Sites (3)

Aarhus University Hosspital

Aarhus, Aarhus N, 8200, Denmark

Location

Horsens Regional Hospital

Horsens, 8600, Denmark

Location

Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

Location

Related Publications (3)

• Jorgensen SL, Aagaard P, Bohn MB, Hansen P, Hansen PM, Holm C, Mortensen L, Garval M, Tonning LU, Mechlenburg I. The Effect of Blood Flow Restriction Exercise Prior to Total Knee Arthroplasty on Postoperative Physical Function, Lower Limb Strength and Patient-Reported Outcomes: A Randomized Controlled Trial. Scand J Med Sci Sports. 2024 Nov;34(11):e14750. doi: 10.1111/sms.14750.

  PMID: 39461901 DERIVED

• Langgard Jorgensen S, Mechlenburg I, Bagger Bohn M, Aagaard P. Sit-to-stand power predicts functional performance and patient-reported outcomes in patients with advanced knee osteoarthritis. A cross-sectional study. Musculoskelet Sci Pract. 2024 Feb;69:102899. doi: 10.1016/j.msksp.2023.102899. Epub 2023 Dec 17.

  PMID: 38141496 DERIVED

• Jorgensen SL, Bohn MB, Aagaard P, Mechlenburg I. Efficacy of low-load blood flow restricted resistance EXercise in patients with Knee osteoarthritis scheduled for total knee replacement (EXKnee): protocol for a multicentre randomised controlled trial. BMJ Open. 2020 Oct 1;10(10):e034376. doi: 10.1136/bmjopen-2019-034376.

  PMID: 33004382 DERIVED

Study Officials

• Stian L Jørgensen, MSc

  Department of Physio and Occupational Therapy, Horsens Regional Hospital

  PRINCIPAL INVESTIGATOR

• Inger Mechlenburg, DMSc, PhD

  Department of Clinical Medicine, Aarhus University, Denmark

  STUDY DIRECTOR

• Per Aagaard, Prof, PhD

  Department of Sports Science and Clinical Biomechanics

  STUDY DIRECTOR

• Marie B Bohn, PhD

  Department of Orthopaedic Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 9, 2019
• Study Start: September 17, 2019
• Primary Completion: June 10, 2023
• Study Completion: April 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Silkeborg Regional Hospital and Aarhus University Horspital agree that information directly related to the protocol and trial, including data, material, Intellectual Property and results generated from the trial shall be the property of Horsens Regional Hospital, and shall be treated in strict confidence, and shall not be disclosed to any third party, or use for its benefit or the benefit of any third party, without the prior written consent of Horsens Regional Hospital, except for data that is (i) publicly known or available from other sources who are not under a confidentially obligation to the other party; (li) has been made available by the other party without confidentiality obligation; or (iii) is independently developed or otherwise already known by or available to the other party without a confidentiality obligation; or (iv) is already required disclosed by law.

Locations

DK (3)