DTOA: Exercise With Dual Task in Knee Osteoarthritis

Sponsor

University of Valencia (Other)

Overall Status

Completed

CT.gov ID

NCT05280080

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

12.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Other: Resistance exercise	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 21, 2022

Actual Primary Completion Date :

May 13, 2022

Actual Study Completion Date :

May 20, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Tampa Scale of Kinesiophobia (TSK 11) [Pre session.]
Its score range is 11-44, with higher scores reflecting worse condition.
Pain Catastrophizing Scale (PCS) [Pre session.]
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.
Chronic Pain Self-Efficacy Scale (CPSS) [Pre session.]
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.
WOMAC questionaire for patients with hip or knee osteoarthritis. [Pre session.]
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.
Heart Rate [Pre exercise, immediate post session, and 10 minutes after session.]
Change from baseline to the end of the session, and the change between the dual-task and the regular condition.
Perceived difficulty of the dual-task. [Immediate post exercise.]
Based on an 11-point numerical rating scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.