Knee OsteoarthristisCaRENCT06857123
Feasibility of Resting Intervals During Exercise Programs for Individuals With Knee Osteoarthritis
A study testing Exercise with Rest and Exercise without Rest in people with Knee Osteoarthristis, run by University of Pittsburgh at 1 site in United States.
Trial summary
This pilot randomize trial tests the feasibility of administering two different exercise programs in people with knee osteoarthritis. One group receives the exercise program administered as usual, and the other group received the exercise program with resting intervals. Read more about this study
- Who is it for?
- Ages 45 to 79 years
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- Exercise with Rest and Exercise without Rest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 45 and 79 yo.
- Clinical diagnosis of primary, early to moderate stage knee osteoarthritis.
- BMI range < 35 kg/m2.
- Sedentary lifestyle
- Knee joint is the most painful joint in the body.
- Ability to speak and understand English.
- Willingness to comply with all study procedures and be available for the duration of the study.
Who cannot join
- Non-OA disease of the knee.
- Advanced knee osteoarthritis
- Knee injection in the past 3 months.
- Major knee trauma/surgery in the past 5 years or previous knee surgery with hardware limiting cartilage assessment..
- Participate in regular exercise or physical activity .
- Participation in an intervention study for knee OA.
Show all 14Show fewer
- Currently using a cane, walker or crutches to walk.
- History of cardiovascular disease or hypertension not controlled by medication.
- Two or more unexplained falls in the past year.
- Inflammatory, autoimmune disorders, neurological, systemic, muscular, or connective tissue conditions that affect walking or ability to exercise.
- Contraindication to MRI.
- Medical condition or characteristic of the participant that could place the individual at increased risk or preclude s/he from complying with study procedures.
- Pregnant female.
- Acute or terminal illness.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Sara R Piva, PhD, PT, FAPTA, 412-383-6712, spiva@pitt.edu
Sara R Piva, PhD, PT, FAPTA
About this study
Official title: Mechanical and Molecular Determinants of Cartilage Response to Exercise
This pilot randomize trial tests the feasibility of administering two different exercise programs in people with knee osteoarthritis. One group receives the exercise program administered as usual, and the other group received the exercise program with resting intervals.
Read the detailed description
Participants will be randomly assigned to 1 of 2 treatment groups. Both groups do the same exercise program 3 times a week for 12 weeks on nonconsecutive days. The only difference is that one group will perform the exercises with small resting periods between exercises as normally done in clinical practice. The other group will have two long rests of 45 minutes during the exercise training session. Before and after the exercise programs, participants will undergo a series of assessments including gait analysis, MRI imaging of knees, tests of muscle strength and physical performance. Questionnaires will be completed. Blood and synovial fluid will be collected as part of this study.
- Conditions
- Knee Osteoarthristis
- Being tested
- Exercise with Rest, Exercise without Rest
- Keywords
- Knee, Osteoarthritis, exercise, feasibility
- Medical subject headings
- Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise with RestBehavioural
Participants in this arm exercise 3 times a week for 12 weeks. Exercise program consists of warm-up, strengthening exercises of the lower major extremity muscle groups, and aerobic training using a treadmill. These sessions include two 45 minute rest periods between exercises and take about two and a half hours.
Exercise without RestBehavioural
Participants in this arm exercise 3 times a week for 12 weeks. Exercise program consists of warm-up, strengthening exercises of the lower major extremity muscle groups, and aerobic training using a treadmill. These sessions include minimal resting periods between exercises and take about one hour.
| Study group | Role | What they receive |
|---|---|---|
| Exercise With Rest | Experimental | Participants in this arm exercise 3 times a week for 12 weeks. Exercise program consists of warm-up, strengthening exercises of the lower major extremity muscle groups, and aerobic training using a treadmill. These sessions include two 45 minute rest periods between exercises and take about two and a half hours. Receives: Behavioral: Exercise with Rest |
| Exercise Without Rest | Active comparator | Exercise without Rest Receives: Behavioral: Exercise without Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
The number of eligible individuals who are randomized out of all eligible individuals.
Measured: The time frame for this outcome is from the enrollment period up to randomization. This outcome measure is independent of treatment assignment.
Secondary outcomes (1)
Safety of interventions
The number of adverse events related to study participation in each arm
Measured: 3 months (window of 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start4 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Carnegie Mellon University
- Responsible party
- Principal investigator, Sara R. Piva, University of Pittsburgh
- Investigators
- Sara Piva, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857123
- Sponsor's protocol ID
- STUDY23050179
- Acronym
- CaRE
- Status last verified
- Feb 2026
- First submitted
- 17 Jan 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data supporting the conclusions of this study will be available upon request to the principal investigators. The data will include participants demographic and biomedical information, along with primary and secondary outcome measures. The data dictionary will be provided.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical and Molecular Determinants of Cartilage Response to Exercise
- ClinicalTrials.gov ID
- NCT06857123
- Acronym / sponsor ID
- CaRE / STUDY23050179
- Conditions
- Knee Osteoarthristis
- Keywords
- Knee, Osteoarthritis, exercise, feasibility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Carnegie Mellon University
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot randomize trial tests the feasibility of administering two different exercise programs in people with knee osteoarthritis. One group receives the exercise program administered as usual, and the other group received the exercise program with resting intervals.
Detailed description
Participants will be randomly assigned to 1 of 2 treatment groups. Both groups do the same exercise program 3 times a week for 12 weeks on nonconsecutive days. The only difference is that one group will perform the exercises with small resting periods between exercises as normally done in clinical practice. The other group will have two long rests of 45 minutes during the exercise training session. Before and after the exercise programs, participants will undergo a series of assessments including gait analysis, MRI imaging of knees, tests of muscle strength and physical performance. Questionnaires will be completed. Blood and synovial fluid will be collected as part of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise With Rest | Experimental | Behavioral: Exercise with RestParticipants in this arm exercise 3 times a week for 12 weeks. Exercise program consists of warm-up, strengthening exercises of the lower major extremity muscle groups, and aerobic training using a treadmill. These sessions include two 45 minute rest periods between exercises and take about two and a half hours. |
| Exercise Without Rest | Active comparator | Behavioral: Exercise without RestExercise without Rest |
Who may qualify
- Ages
- 45 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 45 and 79 yo.
- Clinical diagnosis of primary, early to moderate stage knee osteoarthritis.
- BMI range < 35 kg/m2.
- Sedentary lifestyle
- Knee joint is the most painful joint in the body.
Key exclusion criteria (14 listed)
- Non-OA disease of the knee.
- Advanced knee osteoarthritis
- Knee injection in the past 3 months.
- Major knee trauma/surgery in the past 5 years or previous knee surgery with hardware limiting cartilage assessment..
- Participate in regular exercise or physical activity .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise with RestParticipants in this arm exercise 3 times a week for 12 weeks. Exercise program consists of warm-up, strengthening exercises of the lower major extremity muscle groups, and aerobic training using a treadmill. These sessions include two 45 minute rest periods between exercises and take about two and a half hours. | Behavioural | Exercise With Rest |
| Exercise without RestParticipants in this arm exercise 3 times a week for 12 weeks. Exercise program consists of warm-up, strengthening exercises of the lower major extremity muscle groups, and aerobic training using a treadmill. These sessions include minimal resting periods between exercises and take about one hour. | Behavioural | Exercise Without Rest |
Primary outcome
Feasibility of recruitment
Time frame: The time frame for this outcome is from the enrollment period up to randomization. This outcome measure is independent of treatment assignment.
The number of eligible individuals who are randomized out of all eligible individuals.
1 secondary outcome
Safety of interventions
Time frame: 3 months (window of 1 month)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Yes. The data supporting the conclusions of this study will be available upon request to the principal investigators. The data will include participants demographic and biomedical information, along with primary and secondary outcome measures. The data dictionary will be provided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Piva principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise with Rest and Exercise without Rest in people with Knee Osteoarthristis, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaupp (412-383-0742, awg26@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: The time frame for this outcome is from the enrollment period up to randomization. This outcome measure is independent of treatment assignment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.