Recruiting

Cycling Training

Sponsor:

The University of Tennessee, Knoxville

Code:

NCT04139161

Conditions

Osteoarthritis, Knee

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Q-Factor Intervention

Study Details

Brief summary:

This study is designed to determine the effect of a cycling training program which modulates frontal and sagittal plane knee joint loading with graded increases of Q-Factor and cycling workrate in persons with symptomatic knee osteoarthritis.

Conditions

Osteoarthritis, Knee

Study ID

NCT04139161

Start date

Dec 17, 2019

Status verified date

Apr, 2020

Completion date

May 31, 2021

Anticipated

Primary completion date

May 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Men and Women between the ages of 50 and 75 years old.
  • Diagnosed with medial compartment tibiofemoral osteoarthritis in one of their knees.
  • Be able to walk unaided for at least 25 consecutive minutes.
  • Present with knee pain for at least 6 months occurring on a majority of the days in the month, or on most days (more than or equal to 4 of 7 days in a week) in one or both knees for at least 4 months.
  • Osteophytes on knee x-rays.
  • Grade 2 or higher out of a maximum of 4 on a modified Kellgren/Lawrence grade on the knee radiograph.

Exclusion Criteria:

  • Initial Visual Analog Scale pain scores greater than 7.
  • Diagnosed osteoarthritis of ankles, hips, or symptomatic osteoarthritis of the spine.
  • Arthroplasty of any other lower extremity joint.
  • BMI value greater than 40 kg/m2.
  • Any major lower extremity injury in the past 6 months.
  • Systemic Inflammatory Arthritis.
  • Systemic Pain Conditions.
  • Neurological Conditions that impact gait or cycling.
  • Pregnant or Nursing Women.
  • Major cardiovascular disease with an exercise limitation prescribed by a physician.
  • Steroid injection at the knee within the previous 3 months.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Q-Factor Intervention

Participants will progress through three increasing Q-Factors for each cycling workrate; Q-Factor 1 (Q1, 192mm), Q2 (234mm), Q3 (276mm). After completing bouts of all three Q-Factors for a given workrate, workrate will be increased by 20 Watts and bouts at each Q-Factor will be repeated.

Interventions

Q-Factor Intervention

The intervention period will consist of 12 training sessions across four consecutive weeks, with three training sessions held per week. If pain is not increased or reduced and Rating of Perceived Exertion is ≤12, the participant will progress to the next bout. If pain is increased from the pre-bout pain score, participants will repeat the bout, at the same workrate and Q-Factor settings. Following this fashion, participants will progress through three increasing Q-Factors for each given workrate; Q-Factor 1 (Q1, 192mm), Q2 (234mm), Q3 (276mm). After completing bouts of all three Q-Factors for a given workrate, workrate will be increased by 20 Watts and bouts at each Q-Factor will be repeated. For each training session, participants will complete bouts of cycling until 1) the maximum number of bouts (4 bouts) has been accomplished, 2) self-reported Rating of Perceived Exertion >12, indicating a transition to moderate physical activity, or 3) self-reported pain >5.

Primary outcome measure

  • Knee Abduction Moment - Cycling [ Time Frame: Baseline, 1 month, 2 month ]
  • Knee Abduction Moment - Gait [ Time Frame: Baseline, 1 month, 2 month ]

Central Contacts and Locations

Central contacts

Tanner Thorsen, MS

865-974-2091tthorsen@vols.utk.edu

Songning Zhang, PhD

865-974-4716szhang@utk.edu

Locations

Biomechanics/Sports Medicine Lab

Recruiting

Knoxville, Tennessee, United States, 37996

Contacts

Tanner ThorsenZhang, MS

865-974-2091tthorsen@vols.utk.edu

Songning Zhang, PhD

865-974-4716szhang@utk.edu

Principal Investigator:

Tanner Thorsen, MS

More Information

Sponsor

The University of Tennessee, Knoxville

Last update posted

Apr 7, 2020

Last verified

Apr, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Tennessee, Knoxville on 2020-04-07.