Exercise With Dual Task in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

— DTOA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05280080
• Other study ID #: OA-22-02
• Status: Completed
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: May 20, 2022

Study information

• Verified date: May 2022
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 20, 2022
• Est. primary completion date: May 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Resistance exercise
Do the maximum number of repetitions of externally-resisted (50% 1RM) knee extensions.

Locations

Country	Name	City	State
Spain	Clinic Universitary Hospital of Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	Performance	Maximum number of exercise repetitions performed.	During each experimental session and during each exercise condition.
Secondary	Tampa Scale of Kinesiophobia (TSK 11)	Its score range is 11-44, with higher scores reflecting worse condition.	Pre session.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Perceived difficulty of the dual-task.	Based on an 11-point numerical rating scale.	Immediate post exercise.