ClinicalTrials.gg
CompletedNCT05443295Updated Sep 25, 2025

Improvement of Fatigue in Unstable Shoulder Through a Therapeutic Exercise Program in Physiotherapy

An interventional study of MoveUS Program and Control intervention in Instability, Joint, Shoulder Dislocation and Fatigue, sponsored by University of Malaga. Completed at 2 sites in Spain. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-09-25.

Sponsored by University of Malaga · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

Background: Glenohumeral instability is a highly prevalent pathology; however, there is great controversy in its definition. Traditionally, structural problems such as labral injury or bone loss in the glenoid cavity were considered the main causes; but recently, it has been seen that motor control plays a very relevant role. This means that currently, there is a disparity of action protocols and the treatment of this pathology is a great challenge.

Aim: The primary aim of this study is to evaluate the effectiveness of a supervised multicomponent therapeutic exercise program in reducing multivariable fatigue in patients with instability of the glenohumeral joint.

Methods: A single-blind randomized controlled trial will be carried out, in which 108 adult patients who have suffered at least one episode of glenohumeral instability in the last year will be recruited, who will be randomized to the intervention group, which will carry out a multicomponent therapeutic exercise program supervised by physiotherapists (MoveUS Program); or to the control group, which will receive the usual care. All subjects will be evaluated at baseline, mid-treatment and at the end. In these evaluations, range of movement, maximum peak of isometric force, kinematic, physiological and psychometric fatigue, return to activity, motor control and number of recurrences will be assessed; as well as the quality of life measured through the Western Ontario Shoulder Instability Index, which will be the main outcome variable. A multivariate analysis will be performed through a statistical program.

Discussion: This study aims to determine if therapeutic exercise supervised by physiotherapists is capable of reducing multivariable fatigue, reducing the number of recurrences and improving quality of life; to be able to implement it in the future in public and private centers.

Read the detailed description

The glenohumeral joint presents a high incidence of dislocation (15.3 - 56.3 per 100,000 people per year), which is often accompanied by injury to the glenoid labrum, which increases the number of patients with chronic glenohumeral instability. However, there is great controversy when it comes to giving a clear and agreed definition among experts, since the term \"recurrent glenohumeral instability\" has been used in the scientific literature to encompass a multitude of terms such as dislocation, subluxation, apprehension and instability.

The two common points found in most definitions are discomfort and excessive translation of the humeral head in the glenoid fossa.

Traditionally, biomechanics have attributed glenohumeral instability to structural defects, pointing to bone loss in the glenoid cavity and Hill-Sachs lesion as its main causes. Nonetheless, it has been shown that abnormal muscle activation patterns of the periarticular muscles of the shoulder may be the cause of said instability without the need for there is structural damage.

Taking this last clarification into account, in 2020 a consensus was reached among various experts in the field of shoulder surgery to establish a standard in the classification of functional shoulder instability (FSI), dividing it into two large groups defined as positional FSI, when the shoulder subluxation or dislocation occurs during arm movement and is reduced when returning to neutral position; and non-positional FSI, when this glenohumeral dislocation occurs with the shoulder in a neutral position.

Additionally, a subdivision is made based on the patient\'s ability to control the occurrence of the event: the controllable ones, when the subject is capable of producing and reducing the dislocation voluntarily, almost without symptoms; and uncontrollable when the episode of instability occurs involuntarily, causing more severe pain and functional impotence.

In a more detailed analysis of individuals suffering from functional shoulder instability, electromyography found increased activity in the muscles that stabilize the humeral head and decreased activity in those responsible for mobility. Likewise, a decrease in superointernal scapular rotation was found during arm elevation, generating a descent of the humeral head, which is increased if it is accompanied by ligament hyperlaxity.

The lack of glenohumeral stability can generate a wide variety of signs and symptoms such as pain, limited range of motion, loss of strength, kinesiophobia and a continuous sensation of instability. Added to all this is fatigue, whose early detection can play a very relevant role in the prevention of shoulder injuries, but its evaluation is a great challenge since the term fatigue encompasses several variables.

The kinematic variable refers to both the lack of stability to raise the upper limb and the loss of movement speed. The monitoring of the speed during the execution of the entrusted task can be useful to estimate the number of repetitions that the patient can perform before muscle failure appears.

The physiological variable refers to the inability to generate adenosine triphosphate (ATP) to maintain a movement over time. This insufficiency of metabolic substrate is usually the cause of the so-called neuromuscular fatigue, which has two main axes, central fatigue and peripheral fatigue.

The psychometric variable can manifest itself at the behavioral level, with a decrease in precision in the work carried out; and on a psychological level, with a feeling of exhaustion, weakness and demotivation. This generates an overestimation of the perception of effort and, ultimately, a reduction in physical performance.

In addition to the differentiation of these three variables, when addressing the problem of fatigue, it must be taken into account that there are significant differences related to age and sex.

Taking these findings as a reference, and emphasizing the fact that fatigue is capable of altering the role of the static and dynamic stabilizers of the humeral head, there are already several studies that suggest the need to analyze it in greater depth and establish agreed prevention and rehabilitation protocols in relation to glenohumeral instability.

Exercise plays a fundamental role in this pathology, both in the conservative approach, which is usually the first choice, and in rehabilitation after the surgical approach; since it has been proven that a therapeutic exercise program optimizes the function of dynamic stabilizers that are essential in the maintenance of glenohumeral stability.

In the conservative approach, the Watson program focuses on gaining motor control and stability in the glenohumeral and scapulothoracic joints; and presents six stages that progress over 12 weeks with the strengthening of the axioscapular muscles, the rotator cuff and the deltoid, until the patient is included in their activities of daily living and sports.

This intervention has shown significant improvements compared to other programs such as the Rockwood in the Western Ontario Shoulder Instability Index, in the reduction of pain, in flexor strength and in scapular coordination.

Within this non-surgical approach, the SINEX program is based on 12 weeks of neuromuscular exercises supervised by a physiotherapist with a progression through 7 levels in which strength, coordination, balance and proprioception, as well as the integration of these patterns in functional activities. This intervention reported significant improvements compared to other interventions such as the HOMEX program, especially in apprehension and in the ability to perform sports activities.

Additionally, the influence of the 12-week WIP1 conservative exercise program, through teleconsultation, on atraumatic shoulder instability was analyzed. This program has 6 stages that go through gaining scapular motor control, toning the periarticular muscles, controlling the different planes of movement and integrating movement patterns into specific individualized tasks; reporting significant improvements in stability, shoulder function, strength and scores on specific questionnaires.

When the conservative approach is not successful, there is some trauma in the clinical history or there are concomitant injuries such as Hill-Sachs or Bankart, arthroscopic surgical techniques are used, consisting of the reduction of the joint capsule, since it has been shown that report better long-term results and a lower incidence of recurrence.

After surgery, early supervised mobilization of the involved joint is necessary to optimize the results of the intervention, minimize pain, maximize range of motion and return to sports activity.

The fact of betting on accelerated rehabilitation, in which the patient is subjected to strength and proprioception training with a high demand for skills, to increase precision in stability and joint position, makes it necessary for the exercise program treatment is supervised by a qualified professional in the area.

According to the American Association of Shoulder and Elbow Therapists, rehabilitation after capsulolabral shoulder repair arthroscopy consists of three phases. The first phase focuses on the maximum protection of the surgical sutures. The second phase focuses on achieving functional joint range, submaximal strength, and dynamic stabilization; and the third phase is based on improving neuromuscular function, increasing strength, maximizing joint range and returning the patient to their daily activities and sports practice.

The current challenge in this field is to design an individualized therapeutic exercise program that takes into account the differences in the initial factors between the different individuals, the union between the reduction of symptoms and the return to work and/or sports activity, individual potential, and the conjunction between the protection of tissues and the maximization of capacities; in order to optimize the results of the recovery.

For these reasons, the main objective of this study is to evaluate the effectiveness of a supervised multicomponent therapeutic exercise program in reducing multivariable fatigue in patients with instability of the glenohumeral joint.

02

Conditions studied

  • Instability, Joint
  • Shoulder Dislocation
  • Fatigue
  • Therapeutic Alliance

Keywords

  • instability
  • shoulder
  • fatigue
  • exercise
03

In context

Joint Instability

115 studies on the registry are indexed under Joint Instability; 21 are open to participants now.

This study's enrollment of 108 is above the median of 46 across 58 interventional studies indexed under Joint Instability.

Browse Joint Instability studies →

Lead sponsor

University of Malaga is the lead sponsor of 121 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Having suffered at least one episode of glenohumeral instability in the last year.
  • Age between 18 and 64 years.
  • Have signed the .
  • Score equal to or less than 6 on the Instability Severity Index Score.

Exclusion criteria

Exclusion Criteria:

  • Ethical or cultural barriers.
  • Lack of command of Spanish language.
  • Underlying diseases or concomitant treatments that may affect exercise capacity.
  • Participation in other clinical trials.
  • Score equal to or greater than 1800 on the Western Ontario Shoulder Instability Index.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
108 participants (actual)

Study arms

  • Experimental
    Intervention Group

    The intervention group will carry out the MoveUS Program.

    Other: MoveUS Program

  • Active comparator
    Control Group

    The control group will be subjected to the conventional guidelines in the approach to shoulder instability.

    Other: Control intervention

Interventions

  • OtherMoveUS Program

    The MoveUS Program have 5 stages: 1 (approach stage), based on analytical movements, isometric peak contractions and learning/motor control; 2 (structural stage), based on muscular strength or resistance training through a cumulative work of short efforts, following with the analytical work of pushing or lifting/pulling; and ending in a closed kinetic chain; 3 (neural stage), that has two stage: 3A, based on a structural work that serves as a continuation of stage 2 and the work is focused on the training of increase cross-sectional muscular area; and 3B, based on a neural work focursed in an intra neuromuscular system highlighted motoneuron unit workout. Finally, stage 4 (functional stage), based on a functional readaptation to sports activity and/or work activity; or, failing that, to the activity of daily life with the highest demand.

  • OtherControl intervention

    The control intervention is based on following the conventional treatment guidelines for glenohumeral instability, where immobilization, taking non-steroidal anti-inflammatory drugs, cryotherapy, passive kinesitherapy and self-assisted, pendular exercises stand out and education.

06

What researchers measure

Primary outcomes

  1. Quality of life (WOSI)

    Quality of life is the set of factors that contribute to a person's well-being. It will be assessed through the Western Ontario Shoulder Instability Index

    Time frame: 12 weeks

Secondary outcomes

  1. Range of movement (ROM)

    ROM corresponds to the difference in active and passive joint amplitude, measured with the G-pro smartphone application.

    Time frame: 12 weeks

  2. Scapulo-humeral rhythm (ECH)

    The scapulo-humeral rhythm refers to the motor control capacity of the axioscapular and periarticular muscles of the shoulder to perform the movements of the shoulder joint complex, and will be measured through bipolar surface electromyography

    Time frame: 12 weeks

  3. Kinematic fatigue (Fc)

    Kinematic fatigue refers to the loss during the execution of a movement, and will be assessed with inertial sensors and 3D motion capture system.

    Time frame: 12 weeks

  4. Physiological fatigue (Ff)

    Physiological fatigue refers to the inability to produce adenosine triphosphate to support aerobic and anaerobic efforts; and will be evaluated through high density surface electromyography.

    Time frame: 12 weeks

  5. Psychometric fatigue (Fp)

    Psychometric fatigue translates into a decrease in performance, caused by a feeling of exhaustion, weakness and demotivation. It will be assessed with the Quick Piper Fatigue scale-revised.

    Time frame: 12 weeks

  6. Maximum peak of isometric force (FIM)

    Peak isometric force refers to the maximum voluntary force applied when resistance is insurmountable. It will be quantified with an electromechanical dynamometer.

    Time frame: 12 weeks

  7. Return to play (RTP)

    Return to play is characterized by a person's ability to return to their work and sports routine. It will be evaluated with the "Cuestionario sobre la autopercepción del deportista para la reincorporación al entrenamiento normalizado tras una lesión".

    Time frame: 12 weeks

  8. Number of recurrences (Nº REC)

    The number of recurrences is defined as the number of times the patient suffers from the phenomenon of interest again. It will be recorded through an individualized diary.

    Time frame: 12 weeks

  9. Glenohumeral stability (STAB)

    Functional stability of the glenohumeral joint can be defined as the maintenance of the alignment of the center of the humeral head within the glenoid fossa during movement, achieved through the precise probing of static (passive) and dynamic (active) mechanisms; and will be measured with MoveUS Test.

    Time frame: 12 weeks

  10. Muscular fatigue (Mf)

    Muscle fatigue is, in short, muscle fatigue and occurs when there is extreme exhaustion of muscle fibers due to intense physical activity; and will be measured with Modified T-Fast Test.

    Time frame: 12 weeks

07

Study locations

2 sites
  • Antonio Cuesta Vargas
    Málaga, Málaga, Spain
  • Hospital Comarcal de la Axarquía
    Málaga, Spain
08

References and documents

Publications

  • Ramirez-Perez L, Cuesta-Vargas AI. Effect of the Multicomponent Exercise Program MoveUS on the Kinematic Fatigue of People With Glenohumeral Instability: A Secondary Analysis From a Randomized Controlled Trial. Physiother Res Int. 2026 Jul;31(3):e70258. doi: 10.1002/pri.70258. PubMed 42361116 ↗
  • Ramirez-Perez L, Cuesta-Vargas AI. Shoulder Muscle Activity Through Surface Electromyography and Estimation of Physiological Fatigue Using the T-Fast Test in Patients With Glenohumeral Instability: A Cross-Sectional Study. Physiother Res Int. 2025 Jul;30(3):e70085. doi: 10.1002/pri.70085. PubMed 40543070 ↗
  • Ramirez-Perez L, Cuesta-Vargas AI. Effect of a multicomponent exercise program focused on multivariable fatigue improvement versus standard care for glenohumeral instability: MoveUS study protocol. BMC Musculoskelet Disord. 2024 Dec 18;25(1):1013. doi: 10.1186/s12891-024-08193-4. PubMed 39695629 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2023 to primary completion in Mar 2025, 23 months.

Of 36 non-industry interventional studies with no phase under Joint Instability, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's 23 months is above that.

Counting every sponsor, half of 41 studies reached it within 15 months; a quarter within 7 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2022
First posted
Jul 5, 2022
StartActual
Mar 15, 2023
Primary completionActual
Mar 9, 2025
CompletionActual
Mar 30, 2025
Last update
Sep 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05443295
Collaborators
Instituto de Investigacion Biomedica de Malaga, Queensland University of Technology
Responsible party
Dr. Antonio I Cuesta-Vargas (Physiotherapist. PhD. Professor Department of Physiotherapy, Faculty of Health Sciences, University of Malaga, University of Malaga) — Principal investigator
First posted
Jul 5, 2022
Start date
Mar 15, 2023
Primary completion
Mar 9, 2025
Completion
Mar 30, 2025
Last update
Sep 25, 2025

Study contacts

Cuesta Vargas A Antonio Ignacio, PhD
principal investigator · University of Malaga

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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