NCT05391139

Brief Summary

Elbow injuries account for up to 15% of emergency consultations. The complexity of this joint and the subtle imaging findings present even in severe injuries make diagnosis difficult and can delay treatment, causing pain and functional impotence. Appropriate deterioration mitigation strategies include, but are not limited to, strengthening programs of sufficient intensity to stimulate anabolism and limit muscle loss and increase strength. The general recommendation for increasing muscle strength and neural adaptations in healthy subjects after sustaining an elbow fracture is moderate to heavy load resistance training with loads approximating 60%-80% of the one repetition maximum ( 1RM). However, high joint stress would be challenging and increase the risk of adverse consequences in such patients, so strategies are still needed to meet the challenges of effectively and safely adapting training loads to safely enable improvement. without requiring high joint stress. Resistance band work, coupled with the use of dual tasks, is a novel approach used during resistance training, especially among healthy populations, with promising results. The purpose of the study is to evaluate acute neuromuscular responses, pain intensity and RPE in patients with elbow joint fracture, with or without surgical approach, with different strategies to strengthen the upper limb. Candidates for this study will be men and women over 18 years of age who have been diagnosed with a fracture of the elbow joint (types 1-3 and types 2-1 according to Müller's OA fracture classification), with or without a surgical approach and with date of injury and completion of their physiotherapy program in 2022-2023, and who begin their physiotherapy treatment between weeks 7 to 9 post-fracture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

June 7, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

May 20, 2022

Last Update Submit

January 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mobility

    The experimental protocol begins with the evaluation of neuromuscular responses, self-perceived pain intensity and RPE from the use of different intensities of elastic resistance, during elbow flexion and extension. This intensity is selected because it appears to correspond to the appropriate weight which is equivalent to 30% of 1RM and is considered a light intensity.

    1 day

Secondary Outcomes (5)

  • Kinesiophobia

    1 day

  • Shoulder functionality

    1 day

  • Self-reported pain intensity

    1 day

  • Measurement of range of motion

    1 day

  • Isometric elbow extension/flexion force

    1 day

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Candidates for this study will be men and women over 18 years of age who have been diagnosed with a fracture of the elbow joint (types 1-3 and types 2-1 according to Müller's OA fracture classification), with or without a surgical approach and with date of injury and completion of their physiotherapy program in 2022-2023, and who begin their physiotherapy treatment between weeks 7 to 9 post-fracture.

You may qualify if:

  • Candidates for this study will be men and women over 18 years of age who have been diagnosed with a fracture of the elbow joint. The patients will voluntarily participate in the study, which will be carried out at the Hospital Clínico Universitario de Valencia, during the months of May 2022 to May 2023. All participants will be informed about the objectives and content of the research and information will be obtained. written informed consent. The study will conform to the Declaration of Helsinki and will be approved by the local ethics committee.

You may not qualify if:

  • Participants will be excluded if they have any involvement in the contralateral upper limb, if they have already had/have any other injury to the elbow or other anatomical part of the affected MS (in the last year), and if they have any other condition or disease in the which there is a contraindication to physical exercise. Also if they participate in physiotherapy programs external to the one carried out by us or in other research studies. In addition, if there is evidence of a severe failure in bone consolidation (separation greater than 5 mm), if there is neural injury, CRPS (Complex Regional Pain Syndrome), severe open fracture with muscle and periosteal loss, clinical picture not competent for physiotherapy by diagnosis doubtful and severe congenital instability of upper members.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laura López-Bueno

Valencia, 46005, Spain

Location

MeSH Terms

Conditions

Elbow Fractures

Condition Hierarchy (Ancestors)

Elbow InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Laura López-Bueno

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2022

First Posted

May 25, 2022

Study Start

June 7, 2022

Primary Completion

October 10, 2022

Study Completion

December 20, 2022

Last Updated

January 10, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations