Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05380219 |
| Other study ID # |
ID0001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 5, 2022 |
| Est. completion date |
October 9, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
University of Valencia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 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.
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 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.
First, an observational session will be held. Patients will then be randomized into 2 groups:
one group with strength training and one with strength training and dual task.
