Clinical trial NCT05391139: Acute Effects of Dual Task on Physical Function in Patients With Elbow Joint Fracture
Official title: Acute Effects of Dual Task During Upper Limb Strengthening on Physical Function and Pain in Patients With Elbow Joint Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elbow Fracture
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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.

Detailed description: 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. 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. 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 MMSS. The study consists of observational session will be held. 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, at a controlled speed of 1.5 sec/phase. For this purpose, 1.5 m long elastic bands will be available, which will be previously stretched to approximately 25% of their initial length. 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. At the end of each set of the exercise, you will be asked about RPE (Borg CR10) and pain in the joint. The exercises must be performed with the available range of movement of the subject. Participants are asked to move their body and trunk as little as possible and to perform the exercise smoothly, without stopping or accelerating. Elbow flexion will be performed in a sitting position and extension in the supine position, both stable positions, with exact fastening of the bands on the panel of the Rocher Cage, located in the therapeutic room.

The subjects, in a counterbalanced way, will perform 4 different conditions, with 10 minutes of rest between them: the possibilities are 1) perform all possible repetitions of elbow flexion with the appropriate band; 2) perform all possible repetitions of elbow flexion with the appropriate band, and following a dual task; 3) perform as many elbow extension reps as possible with the appropriate band; 4) perform as many elbow extension repetitions as possible with the appropriate band, and following a dual task.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mobility
timeFrame: 1 day
Secondary outcomes:
measure: Kinesiophobia
timeFrame: 1 day
measure: Shoulder functionality
timeFrame: 1 day
measure: Self-reported pain intensity
timeFrame: 1 day
measure: Measurement of range of motion
timeFrame: 1 day
measure: Isometric elbow extension/flexion force
timeFrame: 1 day
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Laura López-Bueno
Study officials:
affiliation: University of Valencia
name: Laura López-Bueno
role: PRINCIPAL_INVESTIGATOR
References: