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

NCT05443295 | Completed DMC

• 1 other identifier: MoveUS
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Instability, Joint; Shoulder Dislocation; Fatigue; Therapeutic Alliance

Keywords

instability; shoulder; fatigue; exercise

Outcome Measures

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

  12 weeks

Secondary Outcomes (10)

• Range of movement (ROM)

  12 weeks

• Scapulo-humeral rhythm (ECH)

  12 weeks

• Kinematic fatigue (Fc)

  12 weeks

• Physiological fatigue (Ff)

  12 weeks

• Psychometric fatigue (Fp)

  12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will carry out the MoveUS Program.

Other: MoveUS Program

Control Group

ACTIVE COMPARATOR

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

Other: Control intervention

Interventions

MoveUS Program OTHER

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.

Intervention Group

Control intervention OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead
• Instituto de Investigacion Biomedica de Malaga: collaborator
• Queensland University of Technology: collaborator

Study Sites (2)

Antonio Cuesta Vargas

Málaga, Málaga, Spain

Location

Hospital Comarcal de la Axarquía

Málaga, Spain

Location

Related Publications (2)

• 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.

  PMID: 40543070 DERIVED

• 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.

  PMID: 39695629 DERIVED

MeSH Terms

Conditions

Joint Instability; Shoulder Dislocation; Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Joint Dislocations; Wounds and Injuries; Shoulder Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Cuesta Vargas A Antonio Ignacio, PhD

  University of Malaga

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: An external physiotherapist will be used to supervise the intervention carried out, so that the evaluator does not know at any time which group each subject belongs
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist. PhD. Professor Department of Physiotherapy, Faculty of Health Sciences, University of Malaga

Model Details: A single-blind randomized controlled trial.

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: March 15, 2023
• Primary Completion: March 9, 2025
• Study Completion: March 30, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)