Influence of Single Session of Aerobic Exercise on Acute Pain and Function in Patients After Total Knee Replacement

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.

Study Overview

• Status: Unknown
• Conditions: Total Knee Replacement
• Intervention / Treatment: Procedure: aerobic effort; Other: passive pedaling

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noa Katz-Betzalel; Phone Number: 972-50-6534838; Email: noakatzb@gmail.com
• Study Contact Backup: Name: Einat Kodesh, PhD; Phone Number: 972-523489854; Email: ekodesh@univ.haifa.ac.il

Study Locations

• Israel
  • Nahariya, Israel
    • Recruiting
    • Galilee Medical Center
    • Contact: Noa Bezlael Katz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Candidates for unilateral total knee replacement surgery in the Department of Orthopedics 'A", at f the Galilee Medical Center.
• 18 years and older.
• Diagnosed with osteoarthritis.
• Consent to participate in the trial.
• Understand simple instructions.
• Capable of walking with walking aid independently or supervised.
• Allowed to perform medium-intensity aerobic exercise to-60% of their predicted maximum pulse.

Exclusion Criteria:

* Individuals who have a physical limitation preventing them from performing active pedaling in upper limbs for 20 minutes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aerobic effort; Active upper limbs pedaling	Procedure: aerobic effort; 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.
Sham Comparator: passive pedaling	Other: passive pedaling; 20 minutes passive pedaling by upper limbs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure Pain Threshold (PPT)	PPT examination by designated device	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.	Change from Baseline VAS will be assessed right after the intervention
10 Meter Walk Test	timed 10 meter walk test	Change from 10 meter walk test baseline outcome will be assessed right after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Active Range of Motion (aROM)	Goniometer measure	Change in aROM baseline will be assessed right after the intervention
Timed Up and Go (TUG)	Timed Up and Go test	Change from TUG test outcome will be assessed right after the intervention

Collaborators and Investigators

• Sponsor: University of Haifa
• Collaborators: Western Galilee Hospital-Nahariya
• Investigators: Principal Investigator: Einat Kodesh, PhD, University of Haifa; Study Director: Noa Katz-Betzalel, Galilee Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Actual): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 19, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: exercise induced analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: 001 (NavyGHB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No