Late-initiated Blood Flow Restricted Rehabilitation Exercises After Total Knee Replacement

NCT05770934 | Terminated

• 1 other identifier: EXKnee late phase
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will investigate the effectiveness of applying low-load blood flow restricted exercise 12 months after receiving a total knee replacement to achieve a functional capacity-level similar to healthy peers. Participants will be allocated to either an exercise group performing a sit-to-stand exercise 4/weekly with concurrent partial restriction of the blood flow to the limbs or a usual care.

Conditions

Osteoarthritis, Knee; Arthropathy of Knee

Keywords

Rehabilitation; Blood flow restriction exercise; Total knee replacement; Functional Capacity

Outcome Measures

Primary Outcomes (2)

• 30-seconds chair stand test (30-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

  1 year after surgery

• Change in 30-seconds chair stand test (30-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

  15 months after surgery

Secondary Outcomes (17)

• Timed Up & Go (TUG)

  1 yeay after surgery

• Timed Up & Go (TUG)

  15 months after surgery

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

  1 year after surgery

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

  15 months after surgery

• Isometric knee extensor strength

  1 year after surgery

Study Arms (2)

home-based BFRE

EXPERIMENTAL

Patients in the home-based BFRE group will be carefully instructed in how to perform the exercise program with four weekly sessions for 12 weeks (48 training sessions within an 84-day period). Each session will consist of one lower-limb resistance training exercise: sit-to-stand from a \~43 cm high chair. The exercise will consist of four rounds interspaced by a 30-seconds rest pause. The first, second, and third round will consist of 30, 15, 15 repetitions, while the fourth round will be performed until volitional fatigue. The patients will be instructed to perform both the eccentric and concentric contractions at a steady 2-sec pace with, preferably, no time for relaxation in the transition from eccentric to concentric phase (i.e. the bottom is only "kissing" the chair before reversing the movement upwards). When a patient can perform more than 25 repetitions in the last round, they are encouraged to add external resistance corresponding to around 5 kg.

Other: Blood flow restricted low-load resistance exercise

Control Group

NO INTERVENTION

Patients in the control group will performed the same tests 12 months after surgery and 15 months after surgery as the intervention home-based BFRE group.

Interventions

Blood flow restricted low-load resistance exercise OTHER

Blood flow restricted low-load resistance exercise

home-based BFRE

Eligibility Criteria

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

You may qualify if:

• Patients included in the EXknee project (Efficacy of low-load blood flow restricted resistance EXercise in patients with Knee osteoarthritis scheduled for total knee replacement (EXKnee) Jorgensen et al. 2020)

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
• Cancer diagnosis and currently undergoing chemo-, immuno-, or radiotherapy
• Inadequacy in written and spoken Danish
• 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 (1)

Regional Hospital Horsens

Horsens, Horsens, 8700, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: March 16, 2023
• Study Start: April 12, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)