Circulatory Exercise After Total Knee Replacement
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University
About this trial
Total knee replacement is commonly associated with early postoperative inflammation, edema, pain, and reduced mobility. This randomized controlled trial will evaluate whether adding a simple circulatory exercise program to standard postoperative rehabilitation reduces early limb edema and inflammatory response after unilateral primary total knee replacement. Participants will be randomized to standard rehabilitation alone or standard rehabilitation plus seated and supine knee-extension exercises with alternating ankle dorsiflexion. The primary endpoint is change in limb edema measured by standardized limb circumference at postoperative day 14.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ≥ 18 years undergoing elective unilateral primary TKR for osteoarthritis.
Able to provide informed consent.
Able to perform the exercise (cognitively and physically) prior to discharge.
Disqualifiers
Preexisting peripheral vascular disease with severe ischemia or venous insufficiency that limits exercise.
Contraindication to early active movement per surgeon (e.g., complex surgical fixation limiting motion if present).
Severe neurological or cognitive impairment preventing instruction adherence.
Inability to comply with follow-up.
Trial design
Design model
Parallel
Treatments tested in this trial
standard postoperative TKR rehabilitation
Other interventionParticipants will receive standard postoperative total knee replacement rehabilitation according to the local hospital protocol, including early mobilization, ROM exercises, quadriceps activation, ambulation training, and standard pain/edema management as clinically indicated.
Standard Rehabilitation Plus Circulatory Exercise
Other interventionParticipants will receive standard postoperative rehabilitation plus a circulatory exercise protocol including supine leg elevation with ankle pump and knee extension, and seated knee extension with alternating ankle dorsiflexion. The exercise will be performed at approximately 15 cycles/minute, 10 sets of 1 minute, 60 seconds rest between sets, twice daily for 14 postoperative days.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: standard postoperative TKR rehabilitation (hospital protocol)Active comparator 1 intervention
Group B: Circulatory Exercise Protocol (in addition to standard rehab)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Difference in postoperative lower-limb edema between the operated and contralateral limbs measured by standardized limb circumference (cm)
Lower-limb circumference (cm) will be measured bilaterally at standardized anatomical landmarks: 10 cm above the superior border of the patella, at the mid-patellar level, and 20 cm above the superior border of the patella. Measurements will be obtained on both the postoperative limb and the contralateral (sound) limb. Edema will be quantified as the side-to-side difference in circumference and the change from baseline.
Time frame
Baseline/preoperative to postoperative day 14Secondary outcomes
1
Postoperative pain intensity measured by the Numeric Rating Scale (NRS, 0-10) at rest and during activity
Pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores will be recorded at rest and during activity.
Time frame
Baseline/preoperative to postoperative day 142
Functional mobility:
Timed Up and Go (TUG) (go for 3 meter and come back). Record assistance level and gait aids. 3-meter walk test at regular base and fast base.
Time frame
Baseline/preoperative to postoperative day 143
Analgesic consumption
Opioid consumption: record rescue analgesic use
Time frame
Baseline/preoperative to postoperative day 144
Quadriceps strength via handheld dynamometry.
Seated 60 Degrees Knee Flexion Patient position Seated on the edge of the table, with feet not in contact with the ground and knee at 60 degrees of flexion. Contact point Posterior aspect of the ankle attachment, at the hook closest to the achilles tendon. Device orientation Horizontal, linked to the ankle strap at one end and anchored to a fixed surface by the cable strap at the other, posterior to the patient's leg being tested. Position of examiner Adjacent to the patient, in a position to situate the DynaMo and instruct the action. Instruction Pull against the DynaMo as hard as you can. 3, 2, 1 - pull, pull, pull and relax. Attachments Tension links, Carabiners, Ankle strap, Tension strap.
Time frame
Baseline/preoperative to postoperative day 14Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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