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
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable knee-osteoarthritis
Started Mar 2022
Shorter than P25 for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2022
CompletedFirst Posted
Study publicly available on registry
March 15, 2022
CompletedStudy Start
First participant enrolled
March 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2022
CompletedMay 24, 2022
May 1, 2022
2 months
February 15, 2022
May 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (6)
Tampa Scale of Kinesiophobia (TSK 11)
Pre session.
Pain Catastrophizing Scale (PCS)
Pre session.
Chronic Pain Self-Efficacy Scale (CPSS)
Pre session.
WOMAC questionaire for patients with hip or knee osteoarthritis.
Pre session.
Heart Rate
Pre exercise, immediate post session, and 10 minutes after session.
- +1 more secondary outcomes
Study Arms (2)
Regular Task
ACTIVE COMPARATORKnee extensions.
Dual Task
EXPERIMENTALKnee extensions while also doing a self-regulated mathematical dual-task.
Interventions
Do the maximum number of repetitions of externally-resisted (50% 1RM) knee extensions.
Eligibility Criteria
You may qualify if:
- men and women above 55 years old.
- diagnosed with severe knee osteoarthritis.
- scheduled for unilateral TKA surgery in a local hospital during 2021- 2022.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinic Universitary Hospital of Valencia
Valencia, 46010, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
José Casaña
University of Valencia
- STUDY CHAIR
Joaquín Calatayud
University of Valencia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Physiotherapy Department
Study Record Dates
First Submitted
February 15, 2022
First Posted
March 15, 2022
Study Start
March 21, 2022
Primary Completion
May 13, 2022
Study Completion
May 20, 2022
Last Updated
May 24, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share