NCT07904741|Recruiting
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Sponsor study identifier
interventional
60
1 country
1
Study Start
October 20, 2026
Actual (reported)Primary Completion
October 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Knee osteoarthritis can cause pain, reduced muscle strength, and difficulty with daily activities. Exercise is commonly used to manage knee osteoarthritis, but the effects of different exercise programs on muscle oxygenation are not fully understood. This study will compare three 6-week exercise programs in adults with knee osteoarthritis: aerobic exercise on a recumbent bicycle, lower-limb strengthening exercise, and a program combining aerobic and strengthening exercise. Participants will be randomly assigned to one of the three groups. Each group will attend three supervised exercise sessions weekly for 6 weeks. All participants will also receive a home stretching program. Participants will be assessed before the program, at weeks 3 and 6, and again at week 10, after a 4-week period without supervised exercise. The study will examine whether the exercise programs improve muscle oxygenation and whether changes in muscle oxygenation are associated with changes in muscle strength, pain, and physical function. The investigators expect muscle oxygenation to improve after the exercise programs and expect these changes to be associated with improvements in clinical measures.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 20, 2026
Actual (reported)October 23, 2026
Actual (reported)October 29, 2026
Actual (reported)October 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Muscle Oxygenation
1. Resting VMO Muscle Oxygen Saturation (SmO₂): Mean muscle oxygen saturation (SmO₂, %) recorded over 60 seconds after 10 minutes of seated rest, measured over the vastus medialis oblique using near-infrared spectroscopy. 2. Minimum VMO SmO₂ During Mini-Squat Exercise: Minimum muscle oxygen saturation (SmO₂, %) recorded over the vastus medialis oblique during one set of 20 mini-squats performed at approximately 30 degrees of knee flexion, with a 3- to 4-second hold per repetition and isometric hip adduction. 3. Post-Exercise VMO SmO₂ Recovery Time: Time in seconds from completion of the mini-squat set until SmO₂ returns to the pre-exercise resting baseline, measured over the vastus medialis oblique.
Baseline, week 3, week 6, week 10
Knee Pain
Baseline, week 3, week 6, week 10
WOMAC Score
Baseline, week 3, week 6, week 10
SF-36 Health-Related Quality of Life
Baseline, week 3, week 6, week 10
Active Knee Flexion Range of Motion
Baseline, week 3, week 6, week 10
Maximal Isometric Knee Extension Torque
Baseline and weeks 3, 6, and 10.
Participants will complete supervised aerobic exercise on a recumbent cycle ergometer three times per week for 6 weeks (18 sessions). Each session will include a warm-up, cycling, and a cool-down. Exercise intensity and duration will be individually adjusted and progressed according to participant tolerance and pain response, with heart rate and perceived exertion monitored during exercise. Participants will also receive the common home stretching program.
Participants will complete supervised bilateral lower-limb strengthening exercises three times per week for 6 weeks (18 sessions). Exercises will include isometric knee extension, hip flexion, extension, abduction and adduction, clamshell exercise, and knee flexion and extension using ankle weights. The program will use 1 to 3 sets of 8 to 12 repetitions, with resistance progressed according to tolerance and pain response. Participants will also receive the common home stretching program.
Supervised aerobic exercise on a recumbent cycle ergometer, three times per week for 6 weeks (18 sessions). Each session includes a 5-minute warm-up and a 5-minute cool-down. At the beginning of the program, the main cycling will be at 40% to 50% of age-predicted maximum heart rate. Duration and intensity are progressed according to participant tolerance, with a target at 60% to 70% of maximum heart rate by week 6. Cadence is 60 to 80 revolutions per minute. Heart rate and perceived exertion are monitored during exercise.
İstanbul University Cerrahpaşa, Faculty of Health Science, Physiotherapy and Rehabilitation Lab
Istanbul, 34000, Turkey (Türkiye)
First Submitted
October 23, 2026
First Posted
October 29, 2026
Study Start
October 20, 2026
Actual (reported)Primary Completion
October 20, 2027
EstimatedParticipants will complete supervised aerobic exercise on a recumbent cycle ergometer and lower-limb strengthening exercises consecutively during each session, three times per week for 6 weeks (18 sessions). Exercise intensity, duration, and resistance will be adjusted according to the participant's tolerance and pain response. Participants will also receive the common home stretching program.
Supervised bilateral lower-limb strengthening exercise, three times per week for 6 weeks (18 sessions). Exercises include isometric knee extension, hip flexion, extension, abduction and adduction, clamshell exercise, and knee flexion and extension using ankle weights. Participants perform 1 to 3 sets of 8 to 12 repetitions, with 90 to 120 seconds of rest between sets. Resistance starts at approximately 30% of one-repetition maximum and may progress toward 60%, according to tolerance and pain response. One-repetition maximum is reassessed every 2 weeks.
Home flexibility exercises provided to participants in all three arms. The program includes bilateral standing hamstring and quadriceps stretches and a towel-assisted gastrocnemius stretch. Each stretch is held at the point of tension for 20 to 30 seconds. Participants are asked to perform the exercises 3 to 5 days per week.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
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