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

Primary Purpose

Total Knee Replacement

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
aerobic effort
passive pedaling
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Knee Replacement focused on measuring exercise induced analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Galilee Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

aerobic effort

passive pedaling

Arm Description

Active upper limbs pedaling

passive pedaling

Outcomes

Primary Outcome Measures

Pressure Pain Threshold (PPT)
PPT examination by designated device
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.
10 Meter Walk Test
timed 10 meter walk test

Secondary Outcome Measures

Knee Active Range of Motion (aROM)
Goniometer measure
Timed Up and Go (TUG)
Timed Up and Go test

Full Information

First Posted
July 4, 2019
Last Updated
December 19, 2019
Sponsor
University of Haifa
Collaborators
Western Galilee Hospital-Nahariya
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1. Study Identification

Unique Protocol Identification Number
NCT04206709
Brief Title
Influence of Single Session of Aerobic Exercise on Acute Pain and Function in Patients After Total Knee Replacement
Official Title
Influence of Single Session of Aerobic Exercise on Acute Pain and Function in Patients After Total Knee Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Haifa
Collaborators
Western Galilee Hospital-Nahariya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Replacement
Keywords
exercise induced analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
aerobic effort
Arm Type
Experimental
Arm Description
Active upper limbs pedaling
Arm Title
passive pedaling
Arm Type
Sham Comparator
Arm Description
passive pedaling
Intervention Type
Procedure
Intervention Name(s)
aerobic effort
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
passive pedaling
Intervention Description
20 minutes passive pedaling by upper limbs.
Primary Outcome Measure Information:
Title
Pressure Pain Threshold (PPT)
Description
PPT examination by designated device
Time Frame
Change from Baseline PPT will be assessed right after the intervention
Title
Visual Analogue Scale (VAS)
Description
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
Title
10 Meter Walk Test
Description
timed 10 meter walk test
Time Frame
Change from 10 meter walk test baseline outcome will be assessed right after the intervention
Secondary Outcome Measure Information:
Title
Knee Active Range of Motion (aROM)
Description
Goniometer measure
Time Frame
Change in aROM baseline will be assessed right after the intervention
Title
Timed Up and Go (TUG)
Description
Timed Up and Go test
Time Frame
Change from TUG test outcome will be assessed right after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noa Katz-Betzalel
Phone
972-50-6534838
Email
noakatzb@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Einat Kodesh, PhD
Phone
972-523489854
Email
ekodesh@univ.haifa.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Einat Kodesh, PhD
Organizational Affiliation
University of Haifa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Noa Katz-Betzalel
Organizational Affiliation
Galilee Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Galilee Medical Center
City
Nahariya
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noa Bezlael Katz

12. IPD Sharing Statement

Plan to Share IPD
No

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

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