An interventional study of aerobic effort and passive pedaling in Total Knee Replacement, sponsored by University of Haifa. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-20.
Sponsored by University of Haifa · Not applicable, Interventional, and Treatment
The purpose of this study is to examine the immediate effect of aerobic exercise effort on clinical and experimental pain, knee active range of motion and function in people after total knee replacement.
Total knee replacement is a prevalent orthopedic elective surgery in the Western world. After surgery, especially in the first two weeks, patients suffer from high degrees of pain that may lead to delayed recovery, increased risk to chronic pain and pain comorbidities, and may harm the knee function. In purpose to alleviate the pain, most patients tend to passive coping strategies which include the use of high levels of analgesics, including steroids, which may have accompanying side effects.
Aerobic activity is found to have a beneficial effect on pain threshold and pain tolerance in healthy subjects and in chronic pain syndromes. Researches indicate that single bout of aerobic effort increase pain threshold and pain tolerance and decrease pain severity for 15-30 minutes. Until now, the effect of a one-time aerobic effort has not been tested on subjects suffering from acute pain following surgical intervention.
This trail will examine the immediate effect of single aerobic effort on clinical and experimental pain, active knee range of motion and function among people with acute pain after total knee replacement.
40 subjects undergoing total knee replacement at the medical Center for Galilee as a result of Osteoarthritis in one of they knee, will be recruited to the study. The study will take place during the hospitalization in the 5th and 6th days after surgery. In those 2 days the subjects will participate in two meetings: in one session, the participants will be asked to perform active pedaling for 20 minutes in their upper limbs of a pulse that will be calculated approximately 60% of their maximum predictive pulse. in the second meeting the participants will perform passive training with their upper limbs for the same duration. The order of interventions will be randomly determined. Before and after the intervention, it will be examined by pain measures (pressure pain threshold, spontaneous pain perception and arousal pain by the Visual Analogue Scale (VAS) scale), at rest, in a sitting-standing-sitting transfers, while carrying an equal weight on both feet and while walking. the active range of motion of the operated knee, and functional measures - 10 Meters walk Test and Timed Up and Go test.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's planned enrollment of 40 is below the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →University of Haifa is the lead sponsor of 101 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
* Individuals who have a physical limitation preventing them from performing active pedaling in upper limbs for 20 minutes.
Active upper limbs pedaling
Procedure: aerobic effort
passive pedaling
Other: passive pedaling
Active upper limbs pedaling while maintaining a pulse calculated to be approximately 60% of the predicted maximum heart rate of each patient for 20 minutes.
20 minutes passive pedaling by upper limbs.
Pressure Pain Threshold (PPT)
PPT examination by designated device
Time frame: Change from Baseline PPT will be assessed right after the intervention
Visual Analogue Scale (VAS)
100mm VAS -A vertical VAS ruler with a slider indicator and a scale of 0-100 mm on the ruler's front side was used. the lower edge marked "0" and the upper edge marked "100". The back side of the ruler included a "happy" face figure at the lower edge representing "no pain" and a "sad" face at the upper edge representing "severe pain". Higher VAS scores equal more pain.
Time frame: Change from Baseline VAS will be assessed right after the intervention
10 Meter Walk Test
timed 10 meter walk test
Time frame: Change from 10 meter walk test baseline outcome will be assessed right after the intervention
Knee Active Range of Motion (aROM)
Goniometer measure
Time frame: Change in aROM baseline will be assessed right after the intervention
Timed Up and Go (TUG)
Timed Up and Go test
Time frame: Change from TUG test outcome will be assessed right after the intervention
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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University of Haifa