NCT05315934

Brief Summary

The investigators want to compare the effects of upper versus lower body moderate aerobic exercise on the experience of pain in individuals with chronic knee pain. Participants will attend the laboratory on 4 separate occasions to complete a series of exercise tests and experimental pain tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 4, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

1.9 years

First QC Date

May 17, 2020

Last Update Submit

July 26, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Acute Symptomatic Pain

    Change in symptomatic pain measured via Visual Analogue Scale (VAS) from pre- to post-exercise on a 0-10 scale where 0 is no pain at all and 10 is the worst pain imaginable

    Immediately pre and immediately-post exercise

Secondary Outcomes (2)

  • Acute Experimental Pain

    Immediately pre and immediately-post exercise

  • Follow up Symptomatic Pain

    1-7 days post exercise

Study Arms (2)

Upper Body Aerobic Exercise

EXPERIMENTAL

Participants will perform 30 minutes of arm-crank cycling at a moderate exercise intensity based off the participants perceived RPE13

Other: Upper body aerobic exercise

Lower Body Aerobic Exercise

EXPERIMENTAL

Participants will perform 30 minutes of static cycling at a moderate exercise intensity based off the participants perceived RPE13

Other: Lower body aerobic exercise

Interventions

Participants will perform 30 minutes of continuous exercise on the arm-crank ergometer.

Upper Body Aerobic Exercise

Participants will perform 30 minutes of continuous exercise on the cycle ergometer.

Lower Body Aerobic Exercise

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged ≥45 years
  • Male or female
  • Knee pain for ≥3 months
  • Activity related joint pain
  • No joint related morning stiffness, or morning stiffness lasting less than 30 minutes.

You may not qualify if:

  • Specific joint injury within the last 6 months
  • Inability to undertake cycling exercise
  • Use of anti-inflammatory medication
  • Smoker (or having quit \<6 months ago)
  • Osteoarthritis at any upper body sites that would affect ability to complete arm-cycling exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bath

Bath, BA27AY, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor James Bilzon

Study Record Dates

First Submitted

May 17, 2020

First Posted

April 7, 2022

Study Start

February 4, 2020

Primary Completion

January 2, 2022

Study Completion

January 2, 2022

Last Updated

July 29, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Anonymous individual data for all outcomes may be made available.

Locations