NCT06398184

Brief Summary

The main objective of this study is to evaluate the effects of an exercise programme combined with motor imagery and action observation, both in the short and long term.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable knee-osteoarthritis

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 3, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

May 3, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

April 23, 2024

Last Update Submit

April 30, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pain intensity (Visual analogue scale)

    Pain intensity will be measured using a visual analogue scale.

    through study completion, 1 month

  • Disability (WOMAC scale)

    Disability will be measured using WOMAC scale.

    through study completion, 1 month

  • Algometry

    Pressure pain thresholds will be measured by algometry on the affected knee, contralateral knee and epicondyle.

    through study completion, 1 month

Study Arms (2)

Exercise + motor imagery and action observation

EXPERIMENTAL
Other: Exercise + motor imagery and action observation

Exercise

ACTIVE COMPARATOR
Other: Exercise

Interventions

A total of 8 sessions of 4 sets of knee extension exercises will be performed. During the breaks between each series, participants will perform a progressive protocol of action observation and motor imagery.

Exercise + motor imagery and action observation

A total of 8 sessions of 4 sets of knee extension exercises will be performed.

Exercise

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with severe knee OA (according to the clinical and radiographic criteria of the American College of Rheumatology Guidelines)

You may not qualify if:

  • pain in the contralateral (non-studied) limb (maximum ≥80 of 100 mm on a visual analog scale (VAS) during daily activities),
  • undergone another hip or knee joint replacement in the previous year
  • any medical condition in which exercise was contraindicated or if they had participated in exercise programs or motor imagery/action observation intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Luis Suso-Martí, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 23, 2024

First Posted

May 3, 2024

Study Start

May 15, 2024

Primary Completion

October 15, 2024

Study Completion

December 15, 2024

Last Updated

May 3, 2024

Record last verified: 2024-04