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

NCT04206709 | Unknown

• 1 other identifier: 001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Replacement

Keywords

exercise induced analgesia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Knee Active Range of Motion (aROM)

  Change in aROM baseline will be assessed right after the intervention

• Timed Up and Go (TUG)

  Change from TUG test outcome will be assessed right after the intervention

Study Arms (2)

aerobic effort

EXPERIMENTAL

Active upper limbs pedaling

Procedure: aerobic effort

passive pedaling

SHAM COMPARATOR

passive pedaling

Other: passive pedaling

Interventions

aerobic effort PROCEDURE

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.

aerobic effort

passive pedaling OTHER

20 minutes passive pedaling by upper limbs.

passive pedaling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidates for unilateral total knee replacement surgery in the Department of Orthopedics 'A", at f the Galilee Medical Center.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Haifa: lead
• Western Galilee Hospital-Nahariya: collaborator

Study Sites (1)

Galilee Medical Center

Nahariya, Israel

RECRUITING

Study Officials

• Einat Kodesh, PhD

  University of Haifa

  PRINCIPAL INVESTIGATOR

• Noa Katz-Betzalel

  Galilee Medical Center

  STUDY DIRECTOR

Central Study Contacts

Noa Katz-Betzalel

CONTACT

972-50-6534838; noakatzb@gmail.com

Einat Kodesh, PhD

CONTACT

972-523489854; ekodesh@univ.haifa.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: December 20, 2019
• Study Start: January 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: December 20, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)