Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06416540 |
| Other study ID # |
ICU-THERABAND-35 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 21, 2024 |
| Est. completion date |
November 8, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Izmir Democracy University |
| Contact |
Betul Taspinar, Prof. Dr. |
| Phone |
05066804426 |
| Email |
ptbetul[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Intensive Care Unit (ICU) is a special unit that deals with the diagnosis, treatment, and
follow-up of patients who are in critical or severe condition and can not maintain their body
balance. In this unit, appropriate examinations and treatments are applied to patients by
experts using continuous monitoring and advanced technology 24 hours a day, 7 days a week.
Immobilization is often a part of treatment in intensive care units. Long-term immobilization
can lead to respiratory system problems such as mucociliary dysfunction, compromise of airway
integrity, decreased lung capacity and decreased cough efficiency. Theraband exercises have
been used in many settings as part of the therapeutic treatment of patients with poor motor
abilities. However, there is not enough evidence in the literature as there is no study on
the effectiveness of theraband exercises in the intensive care unit. Therefore, the aim of
our study is; To examine the effects of upper extremity theraband exercises on respiratory
functions, muscle strength, functional mobility and quality of life in intensive care
patients.
Description:
Intensive Care Unit (ICU) is a special unit that deals with the diagnosis, treatment and
follow-up of patients who are in critical or severe condition and can not maintain their body
balance. In this unit, appropriate examinations and treatments are applied to patients by
experts using continuous monitoring and advanced technology 24 hours a day, 7 days a week.
Patients who require constant cardiovascular monitoring, need mechanical ventilation and
renal support, have major metabolic disorders, have head trauma, chest injuries or other
multiple injuries are generally admitted to this unit. Although care in the intensive care
unit reduces the mortality risk of patients by up to 60%, controlled mechanical ventilation
can cause musculoskeletal problems due to reasons such as inactivity, sepsis, malnutrition,
insulin resistance and systemic inflammation. Immobilization is often a part of treatment in
intensive care units. Long-term immobilization can lead to respiratory system problems such
as mucociliary dysfunction, compromise of airway integrity, decreased lung capacity and
decreased cough efficiency. These problems are associated with factors such as sedation
practices, artificial airway use, and airway obstruction. These factors disrupt natural
airway clearing mechanisms, make it difficult to expel phlegm, and cause secretion
accumulation. Accumulation of secretion may cause obstruction of the airways, increased
respiratory resistance, alveolar hypoventilation, obstruction atelectasis and the development
of pneumonia. Airway closure can lead to problems associated with body weight, decrease
functional residual capacity, result in consolidation, changes in endotracheal tube position,
pneumonia, lobar atelectasis, collapse, acute respiratory distress syndrome (ARDS), weakness
of respiratory muscles, and lung volume loss due to acute lung injury. Loss of strength in
the respiratory muscles in patients connected to mechanical ventilation frequently triggers
lung complications such as atelectasis, pneumothorax and pneumonia. Decrease in respiratory
function, continued muscle weakness, long-term mechanical ventilation and muscle contractures
may negatively affect patients' quality of life. Inadequate or incomplete treatment is
associated with recurrent symptoms. In addition, immobilization may also trigger
neuromuscular weakness due to disuse atrophy, decreased muscle strength, and functional
impairment. This weakness can range from severe paralysis, with or without loss of deep
tendon reflexes. Acquired muscle weakness involves a complex mechanism. Factors such as
immobility, local and systemic inflammation affect this process. During bed rest, the use of
skeletal muscles decreases, which affects the morphology, contractility and aerobic capacity
of the muscles, causing atrophy and muscle weakness. The period with the greatest loss of
strength is the first week of immobilization. It has been observed that the quality of life
of patients hospitalized in the intensive care unit for a long time decreases and their
dependency increases while performing daily life activities. This condition has been
associated with decreased mobility of patients as a result of muscle weakness and
immobilization. According to studies in the literature, it can generally take an average of
12 months for patients' functional levels to improve after discharge. These findings
emphasize the importance of factors that may affect the quality of life and daily living
activities of patients who stay in the intensive care unit for a long time. Physiotherapists
working in intensive care units deal with the complications and problems associated with this
type of immobilization. Early rehabilitation plays an important role in the management of
these patients to create an appropriate physiotherapy program, increase mobilization levels,
reduce intensive care unit and hospital stays, and improve functional ability. In the
systematic review and meta-analysis by Anekwe et al., in which they examined the effects of
early rehabilitation on preventing the development of muscle weakness in the intensive care
unit, it was revealed that physiotherapy applications in the intensive care unit reduced the
development of acquired muscle weakness in the intensive care unit by a rate ranging from 29%
to 37% in the randomized population. Physiotherapy and rehabilitation practices in intensive
care address the basic problems of patients while also taking into account accompanying
problems. Among the objectives of these interventions are to increase mobility, prevent
muscle weakness and conditioning loss, optimize function, enhance mobility, clear airway
secretions, reduce the frequency of atelectasis and pneumonia, maintain or regain lung
volume, reduce respiratory workload, increase oxygen transport, and improve
ventilation-perfusion matching. These interventions also aim to decrease and prevent
dependence on mechanical ventilation, reduce and correct complications associated with
immobility, minimize morbidity, improve quality of life, increase survival, and minimize the
need for post-intensive care rehabilitation. In intensive care, physiotherapy and
rehabilitation interventions often require the use of different modalities in combination. In
these patients, resistance muscle training can increase muscle mass and force production. In
order for these exercises to be effective, it is recommended to perform 3 sets of 8-10
repetitions at an intensity between 50% and 70% of the maximum repetition, in accordance with
the patient's tolerance. Equipment such as elastic bands and free weights can be used to
perform in-bed exercises, but the use of these equipment should be carefully managed for the
comfort and safety of the patient. These exercises facilitate weaning from mechanical
ventilation and help the patient gain maximum functional capacity. Muscle exercises applied
in the intensive care unit are aimed at achieving goals such as being able to perform basic
daily living activities and walking 20-50 meters independently. Exercise of the lower and
upper extremities is performed in intensive care patients to maintain joint mobility, as well
as to improve soft tissue resistance, muscle strength and functions, and to reduce the risk
of thromboembolism. Lower extremity exercise training programs can increase muscle strength
and endurance in patients with peripheral muscle weakness, which may improve quality of life.
Upper extremity exercises should be included in the program due to their participation in
daily life activities and support for breathing. These exercises target the upper body and
arm muscles, as well as the respiratory muscles. Especially in patients with severe airway
obstruction, the diaphragm must be supported by accessory respiratory muscles because it
cannot create sufficient inspiratory pressure. Unsupported arm exercises can reduce the
support of these muscles for breathing and affect the breathing pattern. The upper extremity
exercise program may include various activities such as arm ergometer, free weights and
elastic bands, thus increasing upper extremity endurance and strength. Theraband is an
elastic band designed to be used for a variety of purposes, introduced by the Akron Hygenic
company in 1978. These bands are available in different colors and resistance levels,
allowing users to tailor their workouts to their needs and skill level. Theraband exercises
have been used in many settings as part of the therapeutic treatment of patients with poor
motor abilities. These exercises provide activation of antagonist, stabilizer and accessory
muscles. One of the most distinctive features that distinguish these bands from other
resistance devices is their ability to work independently of gravity. The resistance of this
flexible exercise band varies depending on how much the user stretches and is therefore based
on tension level, not gravity. As you stretch the Therabands, their resistance increases, so
users can achieve their desired level of difficulty. When using elastic bands, difficulty
levels vary depending on the stretched measurements. Additionally, the colors of these bands
also guide users on their resistance levels. Therabands come in eight different colors, and
each color represents a specific level of difficulty. The color sequence progresses from easy
to difficult, including tan, yellow, red, green, blue, black, gray and golden yellow. This
color-coding system allows users to choose a resistance level that suits their needs and
skill level, and also helps them keep track of their progress. Theraband exercises are an
attractive option that can be preferred in the intensive care unit because it is a cheap and
simple technique. However, the application of theraband exercises in critical illness
situations such as Intensive Care Units has not yet been described in detail. In a case
report, it was shown that upper extremity theraband exercises applied to a patient in the
intensive care unit for 31 days provided significant improvements in the patient's movements.
It was also stated that the patient's ability to maintain a sitting position on the edge of
the bed improved from the 27th day. For this reason, theraband exercises are thought to be a
suitable, safe and applicable method to maintain upper extremity motor activities and improve
trunk control. However, there is not enough evidence in the literature as there is no study
on the effectiveness of theraband exercises in the intensive care unit. Therefore, the aim of
our study is; To examine the effects of upper extremity theraband exercises on respiratory
functions, muscle strength, functional mobility and quality of life in intensive care
patients.
