HealthyNCT05561582

The Effects of Intensity on Exercise-Induced Hypoalgesia During a Knee Extension Exercise

A study testing Seated knee extension exercise in people with Healthy, run by University of Central Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Seated knee extension exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 31 Oct 2022to 27 Mar 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Pain-free
18-60 years old
Participant can appropriately perform the knee extension exercise (assessed during screening)

Who cannot join

Non-English speaking
Regular use of prescription pain medications
Current or history of chronic pain condition
Currently taking blood-thinning medication
Systemic medical condition known to affect sensation, such as uncontrolled diabetes or neurological conditions
Any contraindication to the application of ice, such as: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise

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Known presence of cardiovascular, pulmonary, or metabolic disease
Current use of tobacco products
Not physically ready to exercise without a medical exam as indicated by the Physical Activity Readiness Questionnaire Plus (PAR-Q+)
Surgery, injury, or fracture to the lower back or lower extremity within the past 6 months

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Central Florida
Orlando, Florida, 32765

Other trials in United States

About this study

The primary purpose of this study is to to compare immediate changes in pressure pain threshold at the exercising muscle (quadriceps) and a non-exercising muscle (upper trapezius) during low and high weight knee extension exercise. Participants will attend one session that consists of pain sensitivity testing, completion of pain-related psychological questionnaires, and random assignment to one of three interventions: 1) knee extension exercise with a high weight, 2) knee extension exercise with a low weight, or 3) quiet rest.

Conditions: Healthy
Being tested: Seated knee extension exercise

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Seated knee extension exerciseOther
Participants will be seated in a resistance exercise machine. Weight corresponding to the assigned group will be added to the machine. Participants will extend the dominant knee for 3 sets of 10 repetitions.

Study groups in NCT05561582
Study group	Role	What they receive
High Intensity Exercise	Experimental	Participants will complete a knee extension exercise with weight equivalent to 75% of their 1-repetition maximum for 3 sets of 10 repetitions. Receives: Other: Seated knee extension exercise
Low Intensity Exercise	Experimental	Participants will complete a knee extension exercise with weight equivalent to 30% of their 1-repetition maximum for 3 sets of 10 repetitions. Receives: Other: Seated knee extension exercise
Quiet Rest	No intervention	Participants will sit quietly for two minutes, three times.

What is being measured

The primary outcome is the main question the study is designed to answer.

Pressure Pain Threshold
A digital pressure algometer will be applied to the quadriceps and upper trapezius for two trials each. Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold). Participants will rate the pain experienced during the threshold testing using a 101-point numeric pain rate scale (NPRS) anchored with 0= no pain to 100= the most intense pain sensation imaginable immediately following each testing time.
Measured: 1 day

Secondary outcomes (1)

Conditioned Pain Modulation
Pressure pain threshold after an cold water immersion task will be measured.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 202227 Mar 2023

First posted30 Sep 2022
Study start31 Oct 2022
Primary completion27 Mar 2023
Study completion27 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05561582
Sponsor's protocol ID: 3
Status last verified: Oct 2024
First submitted: 27 Sep 2022
Last updated: 9 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Intensity on Exercise-Induced Hypoalgesia During a Knee Extension Exercise
ClinicalTrials.gov ID: NCT05561582
Acronym / sponsor ID: 3
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University of Central FloridaUniversity, hospital or other
Study start: 31 Oct 2022 (actual)
Primary completion: 27 Mar 2023 (actual)
Study completion: 27 Mar 2023 (actual)
First posted: 30 Sep 2022 (actual)
Results: Posted 9 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
High Intensity Exercise	Experimental	Other: Seated knee extension exerciseParticipants will complete a knee extension exercise with weight equivalent to 75% of their 1-repetition maximum for 3 sets of 10 repetitions.
Low Intensity Exercise	Experimental	Other: Seated knee extension exerciseParticipants will complete a knee extension exercise with weight equivalent to 30% of their 1-repetition maximum for 3 sets of 10 repetitions.
Quiet Rest	No intervention	–Participants will sit quietly for two minutes, three times.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Pain-free
18-60 years old
Participant can appropriately perform the knee extension exercise (assessed during screening)

Key exclusion criteria (10 listed)

Non-English speaking
Regular use of prescription pain medications
Current or history of chronic pain condition
Currently taking blood-thinning medication
Systemic medical condition known to affect sensation, such as uncontrolled diabetes or neurological conditions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Seated knee extension exerciseParticipants will be seated in a resistance exercise machine. Weight corresponding to the assigned group will be added to the machine. Participants will extend the dominant knee for 3 sets of 10 repetitions.	Other	High Intensity Exercise, Low Intensity Exercise

Primary outcome

Pressure Pain Threshold
Time frame: 1 day
A digital pressure algometer will be applied to the quadriceps and upper trapezius for two trials each. Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold). Participants will rate the pain experienced during the threshold testing using a 101-point numeric pain rate scale (NPRS) anchored with 0= no pain to 100= the most intense pain sensation imaginable immediately following each testing time.

1 secondary outcome

Conditioned Pain Modulation
Time frame: 1 day

Results and safety

Results posted to the registry on 9 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Intensity Exercise	20	20
Low Intensity Exercise	20	20
Quiet Rest	20	20

Primary outcome: Pressure Pain Threshold

Time frame: 1 day. Mean (Standard Deviation). Unit: kilopascals

Measure	High Intensity Exercise n = 20	Low Intensity Exercise n = 20	Quiet Rest n = 20
Value	19.11 (77.56)	48.22 (183.06)	-4.14 (88.66)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
High Intensity Exercise	0 of 0	0 of 0
Low Intensity Exercise	0 of 0	0 of 0
Quiet Rest	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Abigail Wilson principal investigator

University of Central Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Seated knee extension exercise in people with Healthy, run by University of Central Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure Pain Threshold (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05561582.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.