Clinical trial NCT04154059: Strengthening Program for Foot-ankle Muscles in People With Knee Osteoarthritis
Official title: Effects of a Strengthening Program for Foot-ankle Muscles in Clinical Aspects and Gait Biomechanics of People With Knee Osteoarthritis: a Randomized Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Rehabilitation
Arthrosis
Therapeutic exercises
Feet
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2019-11-06
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: A randomized controlled trial will be performed with 76 patients with knee osteoarthritis. The participants will be randomly assigned into either a control group (no exercises; they will keep their recommended clinical treatment) or an intervention group which will receive 8-week physical therapy exercises, three times per week, under the supervision of a physiotherapist. Every exercise has its own progression depending on the subjects' execution, increasing in intensity and difficulty.

The subjects will be evaluated in 3 different moments (Baseline, immediately after treatment and 8 weeks follow-up).

The hypothesis of this study is that the intervention group will decrease pain and medication intake, and improve functional performance, increase isometric strength of the feet and production of beneficial biomechanical changes during walking compared to the control group.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline The WOMAC (Western Ontario and McMaster Universities) Pain Subscale at 8 and 16 weeks.
timeFrame: Baseline, 8 weeks and 16 weeks.
Secondary outcomes:
measure: Change from baseline WOMAC (Western Ontario and McMaster Universities) Stiffness Subscale at 8 and 16 weeks.
timeFrame: Baseline, 8 weeks and 16 weeks.
measure: Change from baseline WOMAC (Western Ontario and McMaster Universities) Physical Function Subscale at 8 and 16 weeks.
timeFrame: Baseline, 8 weeks and 16 weeks.
measure: Change from baseline WOMAC (Western Ontario and McMaster Universities) Total Score at 8 and 16 weeks
timeFrame: Baseline, 8 weeks and 16 weeks.
measure: 30-second Chair Stand Test
timeFrame: Baseline, 8 weeks and 16 weeks.
measure: 9-step Stair Climb Test
timeFrame: Baseline, 8 weeks and 16 weeks.
measure: 40m (4x10m) Fast Paced Walk Test
timeFrame: Baseline, 8 weeks and 16 weeks.
measure: Foot strength
timeFrame: Baseline, 8 weeks and 16 weeks.
measure: Foot Kinematics during gait
timeFrame: Baseline, 8 weeks and 16 weeks.
measure: Knee joint moments during gait
timeFrame: Baseline, 8 weeks and 16 weeks.
measure: Global Rating of Change Scale
timeFrame: 8 weeks and 16 weeks.
measure: Paracetamol intake
timeFrame: Baseline, 8 weeks and 16 weeks.
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Glauko Dantas
state: São Paulo
Study officials:
References:
citation: 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.
citation: 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.