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ExerciseNCT06416540

Upper Extremity Theraband Exercises in Intensive Care Patients

A study testing Theraband Exercises plus Conventional Physiotherapy and Rehabilitation Program and Conventional Physiotherapy and Rehabilitation Program in people with Exercise and Intensive Care Unit Patients, run by Izmir Democracy University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Exercise, Intensive Care Unit Patients
What is being tested?
Theraband Exercises plus Conventional Physiotherapy and Rehabilitation Program and Conventional Physiotherapy and Rehabilitation Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteTurkey (Türkiye)
Study dates
21 May 2024to 29 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Being 18 years or older
  • Being conscious
  • Being clinically stable
  • Not dependent on mechanical ventilation
  • Being deemed suitable for physiotherapy and rehabilitation practices by an intensive care specialist

Who cannot join

  • Having psychiatric disorders and extreme agitation
  • Having cooperation disorders
  • Having the progressive neuromuscular disease
  • Having any trauma to the chest wall
  • Having any deformity of the thorax that will affect breathing
  • Having diseases that require constant use of sedative or analgesic agents
  • Being in shock stiuation
  • Having cardiac and respiratory instability (FiO₂> 55%, PaO₂< 65 mmHg, respiratory rate >30 breaths/min, systolic blood pressure >200 mmHg or <80 mmHg, diastolic blood pressure >100 mmHg or <50 mmHg)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Betül TAŞPINAR

    Konak, İ̇zmi̇r

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Upper Extremity Theraband Exercises on Respiratory Functions, Muscle Strength, Functional Mobility and Quality of Life in Intensive Care Patients

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.

Read the detailed 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.

Being tested
Theraband Exercises plus Conventional Physiotherapy and Rehabilitation Program, Conventional Physiotherapy and Rehabilitation Program
Keywords
Intensive Care Units, Exercise, Quality of Life, Physical Therapy Techniques
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Theraband Exercises plus Conventional Physiotherapy and Rehabilitation ProgramOther

    Also called Theraband Exercises in ICU

    Upper extremity, shoulder flexion, abduction, elbow flexion and wrist extension movements will be applied to the study group by the physiotherapist in combination with the breathing pattern. The program will start with yellow therabant and the difficulty level will be increased according to the patient's condition. Exercise training will be applied in a total of 3 sets, 30-60 min/session, 5 days/week, 8-10 repetitions/set, depending on the condition of each patient, during the patients' stay in the intensive care unit.

    Conventional Physiotherapy and Rehabilitation Program Normal joint range movements, airway clearing techniques, breathing exercises and mobilization will be applied to both groups included in the study by the physiotherapist. Hemodynamic and respiratory values for each level are monitored on the monitor. In addition, the patient will be monitored for symptoms such as blackness and dizziness by asking the patient.

  • Conventional Physiotherapy and Rehabilitation ProgramOther

    Also called Control Group

    Normal joint range movements, airway clearing techniques, breathing exercises and mobilization will be applied to both groups included in the study by the physiotherapist. Hemodynamic and respiratory values for each level are monitored on the monitor. In addition, the patient will be monitored for symptoms such as blackness and dizziness by asking the patient.

Study groups in NCT06416540
Study groupRoleWhat they receive
Theraband Exercises plus Conventional Physiotherapy and Rehabilitation Group (TB+CPRG)ExperimentalUpper Extremity Theraband Exercises Program Exercise training will be applied in a total of 3 sets, 30-60 min/session, 5 days/week, 8-10 repetitions/set, depending on the condition of each patient, during the patients' stay in the intensive care unit. Conventional Physiotherapy and Rehabilitation Program Normal joint range movements, airway clearing techniques, breathing exercises and mobilization will be applied to both groups included in the study by the physiotherapist. These movements will be performed once a day for 10 repetitions.
Receives: Other: Theraband Exercises plus Conventional Physiotherapy and Rehabilitation Program; Other: Conventional Physiotherapy and Rehabilitation Program
Conventional Physiotherapy and Rehabilitation Group (CPRG)OtherThe control group will receive only conventional rehabilitation treatment. Although the duration of the session varies depending on the patient's condition, it will last approximately 30-60 minutes. Conventional Physiotherapy and Rehabilitation Program Normal joint range movements, airway clearing techniques, breathing exercises and mobilization will be applied to both groups included in the study by the physiotherapist. These movements will be performed once a day for 10 repetitions.
Receives: Other: Conventional Physiotherapy and Rehabilitation Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of Consciousness

    The patients' consciousness will be evaluated with the Glasgow coma scale. Scores between 3 and 7 indicate severe coma, between 8 and 11 indicate moderate coma, between 12 and 14 indicate mild coma, and 15 points indicate that the patient is not in a coma.

    Measured: At baseline and on average day 10

  2. Assessment of Comorbidity

    The Charlson Comorbidity Index (CKI) will be used to evaluate the patients' accompanying problems. The total CKI score varies between 0-33. As the score increases, the degree of comorbidity also increases.

    Measured: At baseline and on average day 10

  3. Assessment of Disease Severity

    APACHE II score is a measure used to estimate the severity of the disease and the risk of mortality, taking into account the patient's clinical condition and age. This score is based on an initial 12-component score and is evaluated on a range from 0 to 71 points. As the total APACHE II score increases, the severity of the patient's condition also increases.

    Measured: At baseline and on average day 10

  4. Assessment of Respiratory Functions

    Forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), and the ratio of forced expiratory volume in the first second to forced vital capacity (FEV1/FVC) with spirometry will be evaluated.

    Measured: At baseline and on average day 10

  5. Assessment of Peripheral Muscle Strength

    Upper and lower extremity peripheral muscle strength will be evaluated with the Medical Research Council (MRC) scale, which is a manual muscle testing method. Each muscle group is classified between 0 (complete paralysis) and 5 (normal muscle strength) points. The total MRC scale score is evaluated between 0 and 60. MRC score <48 points indicates muscle weakness.

    Measured: At baseline and on average day 10

  6. Assessment of Functional Mobility

    Mobilization status of the participants will be evaluated using the ICU Mobility Scale. The scale includes 11 different mobility levels. These levels range from passive mobilization (0: bedridden) to independent mobilization (10: active mobilization without assistance). As the YMS score increases, the mobility level also increases

    Measured: At baseline and on average day 10

  7. Assessment of Quality of Life

    Participants' quality of life will be assessed using the Nottingham Health Profile (NSP). NSP is a quality of-life scale that aims to evaluate a person's self-perceived health status in emotional, physical, and social aspects. The total score varies between 0-600, and higher scores indicate worse quality of life.

    Measured: At baseline and on average day 10

  8. Assessment of Anxiety and Depression Status

    The anxiety and depression status of the participants will be evaluated using the Hospital Depression and Anxiety Score (HADS). The scale has two subparameters: anxiety (HAD-A) and depression (HAD-D). It consists of fourteen items, seven of which investigate symptoms of depression and seven of which investigate symptoms of anxiety. Answers are scored between 0-3. 0-1 is considered healthy, 2 is borderline and 3-4 is considered sick. As a result of the studies, the cut-off score for the anxiety subscale was found to be 10, and the cut-off score for the depression subscale was found to be 7. Patients can score a minimum of '0' and a maximum of '21' from two subscales.

    Measured: At baseline and on average day 10

  9. Assessment of respiratory muscle strength

    Voluntary measurement of respiratory muscle strength will be made with a portable, electronic mouth pressure measurement device. Maximum static inspiratory pressure (MIP) and maximum static expiratory pressure (MEP) measurement are practical, voluntary measurement methods frequently used in the clinic to measure the strength of the inspiratory and expiratory muscles. The highest pressure value from the measurements will be selected for analysis.

    Measured: At baseline and on average day 10

  10. Assessment of thoracic mobility

    For thoracic mobility, the circumference of the thorax will be measured with a tape measure after expiration and inspiration.

    Measured: At baseline and on average day 10

  11. Assessment of fatigue

    Patients' general perception of body fatigue and dyspnea will be recorded with the Modified Borg scale. A value of 0 indicates no dyspnea and fatigue, and a value of 10 indicates severe dyspnea and fatigue.

    Measured: At baseline and on average day 10

  12. Assessment of hand grip strength

    The patients' hand grip strength will be measured with a Jamar hydraulic hand dynamometer. With the help of the device, measurements will made three times in both hands of the patient and the grip strength is determined by taking the average.

    Measured: At baseline and on average day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2024
  2. Study start21 May 2024
  3. Primary completion22 Jul 2024
  4. Study completion29 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06416540
Sponsor's protocol ID
ICU-THERABAND-35
Status last verified
Jul 2024
First submitted
26 Apr 2024
Last updated
30 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Theraband Exercises plus Conventional Physiotherapy and Rehabilitation Program and Conventional Physiotherapy and Rehabilitation Program in people with Exercise and Intensive Care Unit Patients, run by Izmir Democracy University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of Consciousness (time frame: At baseline and on average day 10). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.

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