Health Education and Exercise Program for Hip Flexibility or Leg Strengthening in people with Knee Osteoarthritis

Protocol for a Feasibility Study of a Randomized Clinical Trial comparing a Health Education Program and Hip Flexibility Exercises versus a Lower Limb Strengthening Program in individuals with Knee osteoarthritis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-6pfv9fb

Enrollment

Registered

2026-03-11

Start date

2026-03-12

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Interventions

This is a feasibility study for a randomized clinical trial conducted in individuals with knee osteoarthritis, with a sample of 20 participants. After baseline assessments, eligible participants will

Eligibility

Age

40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Individuals aged between 40 and 80 years, of both sexes; report of knee pain lasting longer than six months; pain intensity equal to or greater than 4 on a 0 to 10 numeric pain rating scale; diagnosis of knee osteoarthritis confirmed by radiography and classified as grades II, III, or IV according to the Kellgren and Lawrence classification; availability to undergo bilateral knee radiographs

Exclusion criteria

Exclusion criteria: Presence of uncontrolled cardiovascular diseases; medical report contraindicating moderate-intensity physical exercise; cognitive impairment preventing understanding of assessment protocols; diagnosis of fibromyalgia or rheumatoid arthritis; body mass index equal to or greater than 30 kg/m²; participation in exercise under medical prescription; regular physical activity more than twice per week in the last six months; continuous walking longer than 30 minutes daily; diagnosis of hip osteoarthritis; presence of ligament injuries or tendinopathies in lower limbs; history of knee joint surgery; corticosteroid injection in the knee or hip within the last six months; report of pain in the hip, ankle, foot, or lumbar spine with intensity greater than knee pain

Design outcomes

Primary

Measure	Time frame
To evaluate the feasibility and acceptability of implementing a health education and hip flexibility exercise program in individuals with knee osteoarthritis; verified through recruitment, adherence and retention rates, as well as self-reported acceptability using a 0 to 10 numeric scale; it will be observed whether adherence to sessions is equal to or greater than 80%, retention at 12 weeks is equal to or greater than 80%, and at least 90% of outcome data are successfully collected	—

Measure

Time frame

To evaluate the feasibility and acceptability of implementing a health education and hip flexibility exercise program in individuals with knee osteoarthritis; verified through recruitment, adherence and retention rates, as well as self-reported acceptability using a 0 to 10 numeric scale; it will be observed whether adherence to sessions is equal to or greater than 80%, retention at 12 weeks is equal to or greater than 80%, and at least 90% of outcome data are successfully collected

—

Secondary

Measure	Time frame
Investigate the preliminary impact of the intervention on pain intensity; measured using the Numeric Pain Rating Scale ranging from 0 to 10; it will be considered that there was an effect if a minimum reduction of 2 points or a reduction equal to or greater than 30% of baseline pain occurs after 12 weeks. Examine the effect of the intervention on physical function; verified using the Western Ontario and McMaster Universities Osteoarthritis Index with total score ranging from 0 to 96 points; it will be considered that there was an effect if a reduction in the total score occurs after the intervention. Determine the effect of the intervention on pain catastrophizing; measured using the Pain Catastrophizing Scale with total score ranging from 0 to 52 points; it will be considered that there was an effect if a reduction in the total score occurs after the intervention. Verify the effect of the intervention on fear of movement; measured using the Tampa Scale of Kinesiophobia composed of 11 items; it will be considered that there was an effect if a reduction in the total score occurs after the intervention. Examine pain sensitivity; verified through quantitative sensory testing including temporal summation of pain and conditioned pain modulation; it will be considered that there was an effect if a reduction in temporal summation and an increase in conditioned pain modulation occur after the intervention. Examine the functional impact of the intervention; verified using the 30-second chair stand test, the 40-meter fast-paced walk test, and the 9-step stair climb test; it will be considered that there was an effect if an increase in the number of repetitions in the chair stand test and a reduction in completion time in the walking and stair climb tests occur after the intervention. Investigate changes in intersegmental coordination during a functional task; verified through three-dimensional kinematic analysis with calculation of continuous relative phase and its cycle-to-c	—

Measure

Time frame

Investigate the preliminary impact of the intervention on pain intensity; measured using the Numeric Pain Rating Scale ranging from 0 to 10; it will be considered that there was an effect if a minimum reduction of 2 points or a reduction equal to or greater than 30% of baseline pain occurs after 12 weeks. Examine the effect of the intervention on physical function; verified using the Western Ontario and McMaster Universities Osteoarthritis Index with total score ranging from 0 to 96 points; it will be considered that there was an effect if a reduction in the total score occurs after the intervention. Determine the effect of the intervention on pain catastrophizing; measured using the Pain Catastrophizing Scale with total score ranging from 0 to 52 points; it will be considered that there was an effect if a reduction in the total score occurs after the intervention. Verify the effect of the intervention on fear of movement; measured using the Tampa Scale of Kinesiophobia composed of 11 items; it will be considered that there was an effect if a reduction in the total score occurs after the intervention. Examine pain sensitivity; verified through quantitative sensory testing including temporal summation of pain and conditioned pain modulation; it will be considered that there was an effect if a reduction in temporal summation and an increase in conditioned pain modulation occur after the intervention. Examine the functional impact of the intervention; verified using the 30-second chair stand test, the 40-meter fast-paced walk test, and the 9-step stair climb test; it will be considered that there was an effect if an increase in the number of repetitions in the chair stand test and a reduction in completion time in the walking and stair climb tests occur after the intervention. Investigate changes in intersegmental coordination during a functional task; verified through three-dimensional kinematic analysis with calculation of continuous relative phase and its cycle-to-c

—

Countries

Contacts

Public ContactMarialice Da Silva

Universidade Federal de São Carlos

alicegyaraki@gmail.com+55-16-981587938

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Apr 4, 2026