NCT04139161

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 17, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

1.5 years

First QC Date

October 22, 2019

Last Update Submit

April 6, 2020

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

  • Knee Abduction Moment - Cycling

    Change in Knee Extension Moment during cycling.

    Baseline, 1 month, 2 month

  • Knee Abduction Moment - Gait

    Change in Knee Extension Moment during gait.

    Baseline, 1 month, 2 month

Secondary Outcomes (4)

  • Visual Analog Pain

    Immediately following exercise (walking and cycling).

  • Knee Extension Moment - Cycling

    Baseline, 1 month, 2 month

  • Knee Extension Moment - Gait

    Baseline, 1 month, 2 month

  • Knee Injury and Osteoarthritis Outcome Score

    Baseline, 1 month, 2 month

Study Arms (1)

Q-Factor Intervention

EXPERIMENTAL

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.

Procedure: Q-Factor Intervention

Interventions

Q-Factor InterventionPROCEDURE

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.

Q-Factor Intervention

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomechanics/Sports Medicine Lab

Knoxville, Tennessee, 37996, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Tanner Thorsen, MS

    University of Tennessee, Knoxville

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanner Thorsen, MS

CONTACT

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

Songning Zhang, PhD

CONTACT

865-974-4716szhang@utk.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Research Assistant

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 25, 2019

Study Start

December 17, 2019

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

April 7, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)