Strengthening Program for Foot-ankle Muscles in People With Knee Osteoarthritis

NCT04154059 | Terminated

• 1 other identifier: LabPlastUFSCar
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this trial is To evaluate the effect of an ankle and foot muscle strengthening program on pain, analgesic consumption, functionality, and lower limb biomechanics during gait in individuals with knee osteoarthritis.

Conditions

Knee Osteoarthritis

Keywords

Rehabilitation; Arthrosis; Therapeutic exercises; Feet

Outcome Measures

Primary Outcomes (1)

• Change from baseline The WOMAC (Western Ontario and McMaster Universities) Pain Subscale at 8 and 16 weeks.

  The WOMAC pain subscale consists of five questions (Likert Scale) relating to the patient's pain in everyday situations. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of pain subscale ranges from 0 to 20. Higher scores indicate worse pain.

  Baseline, 8 weeks and 16 weeks.

Secondary Outcomes (11)

• Change from baseline WOMAC (Western Ontario and McMaster Universities) Stiffness Subscale at 8 and 16 weeks.

  Baseline, 8 weeks and 16 weeks.

• Change from baseline WOMAC (Western Ontario and McMaster Universities) Physical Function Subscale at 8 and 16 weeks.

  Baseline, 8 weeks and 16 weeks.

• Change from baseline WOMAC (Western Ontario and McMaster Universities) Total Score at 8 and 16 weeks

  Baseline, 8 weeks and 16 weeks.

• 30-second Chair Stand Test

  Baseline, 8 weeks and 16 weeks.

• 9-step Stair Climb Test

  Baseline, 8 weeks and 16 weeks.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients will receive a physical therapy intervention three times per week, for 8 weeks.

Other: Intervention Group

Control Group

NO INTERVENTION

Patients will not receive any exercise treatment but they will keep their recommended clinical treatment.

Interventions

Intervention Group OTHER

Patients will receive a physical therapy intervention for strengthening, stretching and functional training of ankle and foot.

Also known as: Foot and ankle kinesiotherapy

Intervention Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Knee osteoarthritis (KOA) based on clinical and radiological criteria of American College of Reumathology;
• KOA (Grade II and III - Radiological classification of Kellgreen and Laurence) in medial compartment of knee;
• Knee pain between 30 and 80 on the visual analogue scale;
• BMI \< 35 kg/m2.

You may not qualify if:

• KOA isolated (Grade II and III - Radiological classification of Kellgreen and Laurence) in lateral compartment of knee;
• Lower limb strength training (3 times per week);
• Wear minimalist shoes for at least 6 hours a day and 5 days a week;
• Physical therapy in the previous 3 months;
• Having received steroid injections and hyaluronic acid intra-articular knee in previous periods of three and six months respectively;
• Previous history of surgery on knees, ankles and hips in the last 2 years;
• Neurological disease;
• Inflammatory arthritis (eg. rheumatoid arthritis);
• Asymptomatic OA of one or both knees.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead
• University of Sao Paulo: collaborator

Study Sites (1)

Glauko Dantas

São Carlos, São Paulo, Brazil

Location

Related Publications (2)

• Dantas G, Sacco ICN, Dos Santos AF, Watari R, Matias AB, Serrao PRMS, Pott-Junior H, Salvini TF. Effects of a foot-ankle strengthening programme on clinical aspects and gait biomechanics in people with knee osteoarthritis: protocol for a randomised controlled trial. BMJ Open. 2020 Sep 25;10(9):e039279. doi: 10.1136/bmjopen-2020-039279.

  PMID: 32978204 RESULT

• Dantas GAF, Sacco ICN, Ferrari AV, Matias AB, Watari R, Oliveira LVM, Marcon TR, Fatore JA, Pott-Junior H, Salvini TF. Effects of a foot-ankle muscle strengthening program on pain and function in individuals with knee osteoarthritis: a randomized controlled trial. Braz J Phys Ther. 2023 Jul-Aug;27(4):100531. doi: 10.1016/j.bjpt.2023.100531. Epub 2023 Aug 11.

  PMID: 37603935 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (MSc)

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 6, 2019
• Study Start: January 27, 2020
• Primary Completion: March 1, 2020
• Study Completion: August 4, 2023
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Participant data that underlie the results reported in this paper will be shared after blinding (text, tables, figures, appendices), immediately following publication.
• Access Criteria: Requests for data or any form of analysis should be directed to glauko.ft.andre@hotmail.com or tania@ufscar.br. Requesters will be asked to sign a data access agreement.

Locations

BR (1)