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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-79
SponsorUniversity of Pittsburgh

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 45 and 79 yo.

Clinical diagnosis of primary, early to moderate stage knee osteoarthritis.

BMI range < 35 kg/m2.

Sedentary lifestyle

Disqualifiers

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..

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise with Rest

    Behavioral

    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 Rest

    Behavioral

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Exercise With RestExperimental treatment 1 intervention
Group B: Exercise Without RestActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of recruitment

The number of eligible individuals who are randomized out of all eligible individuals.

Time frame
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

Time frame
3 months (window of 1 month)

Other outcomes

1

Adherence to Intervention

The number of intervention sessions attended out of the total number of intervention sessions prescribed in the study.

Time frame
3 months (window of 1 month)
2

Study retention

The number of participants in each intervention arm who attend the follow-up assessment visit out of the number of participants randomized to each intervention arm.

Time frame
3 months (window of 1 month)

Sponsors and contacts

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University of Pittsburgh

Lead sponsor

Carnegie Mellon University

Collaborator