Clinical Trial Finder

Feasibility of Resting Intervals During Exercise Programs for Individuals With Knee Osteoarthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 45 Years - 79 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age between 45 and 79 yo.
  • - Clinical diagnosis of primary, early to moderate stage knee osteoarthritis.
  • - BMI range of 25 to 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.

Exclusion Criteria:

  • - 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.
  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06857123
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Pittsburgh
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Sara Piva
Principal Investigator Affiliation University of Pittsburgh
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Knee Osteoarthristis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Exercise With Rest

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.

Active Comparator: Exercise Without Rest

Exercise without Rest

Interventions

Behavioral: - Exercise with Rest

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.

Behavioral: - Exercise without Rest

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Pittsburgh, Pittsburgh 5206379, Pennsylvania 6254927

Status

Recruiting

Address

University of Pittsburgh

Pittsburgh 5206379, Pennsylvania 6254927, 15213

Site Contact

Sara R Piva, PhD, PT, FAPTA

[email protected]

412-383-6712

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