- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06416540
Upper Extremity Theraband Exercises in Intensive Care Patients
The Effect of Upper Extremity Theraband Exercises on Respiratory Functions, Muscle Strength, Functional Mobility and Quality of Life in Intensive Care Patients
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
İ̇zmi̇r
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Konak, İ̇zmi̇r, Turkey
- Betül TAŞPINAR
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Theraband Exercises plus Conventional Physiotherapy and Rehabilitation Group (TB+CPRG)
Upper 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. |
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.
Other Names:
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.
Other Names:
|
|
Other: Conventional Physiotherapy and Rehabilitation Group (CPRG)
The 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. |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of Consciousness
Time Frame: At baseline and on average day 10
|
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.
|
At baseline and on average day 10
|
|
Assessment of Comorbidity
Time Frame: At baseline and on average day 10
|
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.
|
At baseline and on average day 10
|
|
Assessment of Disease Severity
Time Frame: At baseline and on average day 10
|
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.
|
At baseline and on average day 10
|
|
Assessment of Respiratory Functions
Time Frame: At baseline and on average day 10
|
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.
|
At baseline and on average day 10
|
|
Assessment of Peripheral Muscle Strength
Time Frame: At baseline and on average day 10
|
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.
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At baseline and on average day 10
|
|
Assessment of Functional Mobility
Time Frame: At baseline and on average day 10
|
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
|
At baseline and on average day 10
|
|
Assessment of Quality of Life
Time Frame: At baseline and on average day 10
|
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.
|
At baseline and on average day 10
|
|
Assessment of Anxiety and Depression Status
Time Frame: At baseline and on average day 10
|
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.
|
At baseline and on average day 10
|
|
Assessment of respiratory muscle strength
Time Frame: At baseline and on average day 10
|
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.
|
At baseline and on average day 10
|
|
Assessment of thoracic mobility
Time Frame: At baseline and on average day 10
|
For thoracic mobility, the circumference of the thorax will be measured with a tape measure after expiration and inspiration.
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At baseline and on average day 10
|
|
Assessment of fatigue
Time Frame: At baseline and on average day 10
|
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.
|
At baseline and on average day 10
|
|
Assessment of hand grip strength
Time Frame: At baseline and on average day 10
|
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.
|
At baseline and on average day 10
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pınar Unde Ayvat, Assoc. Prof., Izmir Democracy University
- Principal Investigator: Ferruh Taspinar, Prof. Dr., Izmir Democracy University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ICU-THERABAND-35
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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