Exercise With Dual Task in Knee Osteoarthritis (DTOA)

Neuromuscular and Perceptual Responses, Pain Intensity and Performance During Resistance Exercise With a Self-regulated Dual-task in Patients With Severe Knee Osteoarthritis

The purpose of this study is to evaluate the neuromuscular and perceptual responses, pain intensity and performance in patients with severe knee osteoarthritis in a preoperative setting with low-load resistance training with a self-regulated mathematical dual-task.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Resistance exercise

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Clinic Universitary Hospital of Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• men and women above 55 years old.
• diagnosed with severe knee osteoarthritis.
• scheduled for unilateral TKA surgery in a local hospital during 2021- 2022.

Exclusion Criteria:

• pain in the contralateral limb (maximum pain, ≥80 of 100 mm on a VAS during daily activities).
• another hip or knee joint replacement in the previous year.
• any medical condition in which exercise was contraindicated.
• participated in exercise programs (>2 days/week, training at intensities of 10-15RM) in the 6 months prior to the study.
• history of stroke, brain surgery, major depression, or any self-perceived cognitive alterations that could affect the performance of dual tasks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Regular Task; Knee extensions.	Other: Resistance exercise; Do the maximum number of repetitions of externally-resisted (50% 1RM) knee extensions.
Experimental: Dual Task; Knee extensions while also doing a self-regulated mathematical dual-task.	Other: Resistance exercise; Do the maximum number of repetitions of externally-resisted (50% 1RM) knee extensions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)	Change from baseline to the end of the session, and the change between the dual-task and the regular condition.	Pre exercise, immediate post session, and 10 minutes after session.
Pressure pain thresholds	Change from baseline to the end of the session, and the change between the dual-task and the regular condition.	Pre exercise, immediate post session, and 10 minutes after session.
HDsEMG	Change from baseline to the end of the session, and the change between the dual-task and the regular condition.	During each experimental session and during each exercise condition.
Performance	Maximum number of exercise repetitions performed.	During each experimental session and during each exercise condition.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tampa Scale of Kinesiophobia (TSK 11)	Its score range is 11-44, with higher scores reflecting worse condition.	Pre session.
Pain Catastrophizing Scale (PCS)	People are asked to indicate the degree to which they have certain thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness, with higher scores reflecting worse condition.	Pre session.
Chronic Pain Self-Efficacy Scale (CPSS)	The Chronic Pain Self-Efficacy Scale (CPSS) is designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain. The CPSS measures three domains of pain self-efficacy: pain management, physical functioning, and coping with symptoms. A total score is yielded (ranging from 220-2200), with higher scores reflecting a better condition.	Pre session.
WOMAC questionaire for patients with hip or knee osteoarthritis.	The WOMAC is a disease-specific self-administered questionnaire for patients with hip or knee osteoarthritis. It has a multidimensional scale made up of 24 items grouped into three dimensions: pain (5 items), stiffness (2 items) and physical function (17 items). For each item, it uses a Likert scale with five response levels, representing different degrees of intensity (none, mild, moderate, severe or extreme) that are scored from 0 to 4. The final score for the WOMAC is determined by adding the aggregate scores for pain, stiffness and function. The higher the score, the worse the patient's condition.	Pre session.
Heart Rate	Change from baseline to the end of the session, and the change between the dual-task and the regular condition.	Pre exercise, immediate post session, and 10 minutes after session.
Perceived difficulty of the dual-task.	Based on an 11-point numerical rating scale.	Immediate post exercise.

Collaborators and Investigators

• Sponsor: University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Actual): May 13, 2022
• Study Completion (Actual): May 20, 2022

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: March 5, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Electromyography; Knee Osteoarthritis; Resistance Training; Muscle Activity
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: OA-22-02

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