Supraspinatus Tendon Acute Effects After Two Exercise Exposures: a Crossover Randomized Trial.

April 21, 2026 updated by: University of Florida
The purpose of this study is to understand acute tendon changes after two exercise programs. We will invite individuals with and without shoulder pain to participate in this study. Every individual will participate in both exercise programs separated by up to 15 days. The researcher will evaluate the shoulder tendon using ultrasound before each exercise program and at 1 hour, 6 hours and 24 hours after each exercise program. The researcher will also evaluate self reported pain, pain sensitivity testing, and self reported questionnaires. We will compare the tendon changes after each exercise program, as well as between participants with and without shoulder pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ignacio A Raguzzi, PT
  • Phone Number: 352-665-4947
  • Email: iraguzzi@ufl.edu

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida
        • Contact:
        • Principal Investigator:
          • Ignacio A Raguzzi, PT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

General inclusion criteria

  1. Between 18 and 45 years of age
  2. Able to perform physical activity with their shoulder (moderate arm exercise for 15 min, such as tennis or housework)

General exclusion criteria

  1. Shoulder fracture
  2. Frozen shoulder (>50% restriction in shoulder range of motion)
  3. Shoulder surgery
  4. Full rotator-cuff tears
  5. Bilateral shoulder pain
  6. Shoulder instability (history or positive apprehension test)
  7. Corticosteroid injection in the last 6 weeks
  8. Neurological diseases
  9. Cardiological diseases
  10. Systemic diseases (rheumatic diseases, autoimmune diseases)
  11. Uncontrolled diabetes
  12. Pregnancy

Group-specific inclusion criteria

  1. Shoulder pain group: report unilateral shoulder pain with an average shoulder pain score of≥ 3 in the last week.
  2. Control group: report no shoulder pain within 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Isotonic exercise then Plyometric exercise
Behavioral: Isotonic exercise program
Participants will perform two isotonic exercises, prone shoulder external rotation and shoulder elevation. The exercises will be performed at a pace of 2-second for both concentric and eccentric phases. For each exercise, participants will perform two sets of 8 repetitions, followed by a third set performed until fatigue. Fatigue will be determined using the Repetition in Reserve Scale, which asks the participant to perform exercises until they reach a self-selected number corresponding to the number of repetitions left that a participant could still complete if needed. We will ask participants to continue the third set until they reach a Repetition in Reserve number of 1. The rest period will be 30 seconds between sets and 2 minutes between exercises. The exercise load will be selected after manual maximal isometric strength testing using a handheld dynamometer. A 40% of the strength testing will be used for exercises in both groups following strength guidelines.
Behavioral: Plyometric exercise program
Participants will perform two isotonic exercises, prone shoulder external rotation and shoulder elevation. The exercises will be performed at a pace of 1-second for the eccentric phases followed by an explosive concentric phase. For each exercise, participants will perform two sets of 8 repetitions, followed by a third set performed until fatigue. Fatigue will be determined using the Repetition in Reserve Scale, which asks the participant to perform exercises until they reach a self-selected number corresponding to the number of repetitions left that a participant could still complete if needed. Participants will complete the third set until they reach a Repetition in Reserve number of 1. The rest period will be 30 seconds between sets and 2 minutes between exercises. The exercise load will be selected after manual maximal isometric strength testing using a handheld dynamometer. A 40% of the strength testing will be used for exercises in both groups following strength guidelines.
Experimental: Plyometric exercise then Isotonic exercise
Behavioral: Isotonic exercise program
Participants will perform two isotonic exercises, prone shoulder external rotation and shoulder elevation. The exercises will be performed at a pace of 2-second for both concentric and eccentric phases. For each exercise, participants will perform two sets of 8 repetitions, followed by a third set performed until fatigue. Fatigue will be determined using the Repetition in Reserve Scale, which asks the participant to perform exercises until they reach a self-selected number corresponding to the number of repetitions left that a participant could still complete if needed. We will ask participants to continue the third set until they reach a Repetition in Reserve number of 1. The rest period will be 30 seconds between sets and 2 minutes between exercises. The exercise load will be selected after manual maximal isometric strength testing using a handheld dynamometer. A 40% of the strength testing will be used for exercises in both groups following strength guidelines.
Behavioral: Plyometric exercise program
Participants will perform two isotonic exercises, prone shoulder external rotation and shoulder elevation. The exercises will be performed at a pace of 1-second for the eccentric phases followed by an explosive concentric phase. For each exercise, participants will perform two sets of 8 repetitions, followed by a third set performed until fatigue. Fatigue will be determined using the Repetition in Reserve Scale, which asks the participant to perform exercises until they reach a self-selected number corresponding to the number of repetitions left that a participant could still complete if needed. Participants will complete the third set until they reach a Repetition in Reserve number of 1. The rest period will be 30 seconds between sets and 2 minutes between exercises. The exercise load will be selected after manual maximal isometric strength testing using a handheld dynamometer. A 40% of the strength testing will be used for exercises in both groups following strength guidelines.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Supraspinatus tendon thickness
Time Frame: From enrollment to 1 hour, 6 hours, and 24 hours after each exercise program.
The investigators will use ultrasound to take pictures of the supraspinatus tendons. Established ultrasound procedures will be used to measure supraspinatus tendon thickness.
From enrollment to 1 hour, 6 hours, and 24 hours after each exercise program.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain sensitivity testing
Time Frame: From enrollment to 1 hour, 6 hours, and 24 hours after each exercise program.
The investigators will apply pressure at a constant rate using a computerized pressure algometer with a 1 cm diameter rubber tip at the shoulder and the lower limb.
From enrollment to 1 hour, 6 hours, and 24 hours after each exercise program.
Self-reported pain
Time Frame: From enrollment to 1, 6, and 24 hours after each exercise program.
We will use an 11-point numeric pain rating scale to measure the shoulder pain perceived by the participant.
From enrollment to 1, 6, and 24 hours after each exercise program.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of perceived exertion
Time Frame: Immediately after each exercise program.
We will use a 11-point scale, 0 being no effort and 10 being the maximal effort, to understand the effort perceived after each exercise program.
Immediately after each exercise program.
Pennsylvania Shoulder Score (PENN)
Time Frame: At baseline before each exercise program.
The PENN is a valid and reliable self-reported questionnaire for patients with shoulder pain.
At baseline before each exercise program.
Optimal Screening for Prediction of Referral and Outcome (OSPRO)
Time Frame: At baseline before the first exercise program.
The OSPRO is a concise, multidimensional 10-item yellow flag assessment tool that estimates 11 total questionnaire scores indicating elevated vulnerability and decreased resilience.
At baseline before the first exercise program.
Global rating of change (GROC)
Time Frame: At the second baseline before the second exercise program at 1 week.
The GROC is a rating scale that quantifies participants' improvement or deterioration of symptoms over time. Changes will be measured using a 15-points Likert scale (-7, a very great deal worse to 7, a very great deal better, with 0 indicating no changes).
At the second baseline before the second exercise program at 1 week.
Tegner Activity Scale
Time Frame: At baseline before the first exercise program.
Is a valid and reliable tool that evaluates work and sport participation. It addresses both function and activity level, and it will provide information about the physical general activity of the individual.
At baseline before the first exercise program.
Rate of perceived fatigue
Time Frame: Immediately after each exercise program
We will use a 11-point scale, 0 being no fatigue and 10 being the maximal fatigue, to understand the fatigue perceived after each exercise program.
Immediately after each exercise program
Self-reported pain related to the exercise
Time Frame: Before and immediately after each exercise program
We will use an 11-point numeric pain rating scale to measure the shoulder pain perceived by the participant.
Before and immediately after each exercise program
Muscle soreness
Time Frame: Before and immediately, 1, 6 and 24 hours after each exercise program
We will use an 11-point numeric rating scale to measure the muscle soreness perceived by the participant after the exercise.
Before and immediately, 1, 6 and 24 hours after each exercise program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB202501875

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Study protocol & statistical analysis plan: A manuscript describing the study protocol and statistical analysis plan will be submitted for publication before the end of the recruitment for the study.

IPD Sharing Access Criteria

Study protocol and statistical analysis plan: The manuscript will be published as open access.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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