Late-initiated Blood Flow Restricted Rehabilitation Exercises After Total Knee Replacement
Key facts
- Who runs it
- University of Aarhus
- Where
- Denmark1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 56 people enrolled
- Started
- 12 Apr 2023
- Ended
- 30 Aug 2024
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Blood flow restricted low-load resistance exercise
- Record updated
- 23 September 2024
- Why it stopped
- No participant wanted to participate
Who can take part
- Age
- 50 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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)
Who cannot take part
- previous stroke incident, thrombosis incident
- Severe cardiovascular diseases (New York Heart Association class III and IIII), -
- Unregulated hypertension (Systolic ≥180 or diastolic ≥110 mmHg)
- Cancer diagnosis and currently undergoing chemo-, immuno-, or radiotherapy
- Traumatic nerve injury in affected limb
- Spinal cord injury
- Inadequacy in written and spoken Danish
- living more than 45 minutes from either Horsens Regional Hospital or Silkeborg Regional Hospital
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- home-based BFRETreatment being tested
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.
Treatment: Blood flow restricted low-load resistance exercise
- Control GroupNo study treatment, for comparison
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Effectiveness of Late-initiated Blood Flow Restricted Rehabilitation Exercises on Functional Capacity, Lower Limb Muscle Strength and Patient-reported Outcomes After Total Knee Replacement
- Record updated
- 23 September 2024