Upper Extremity Theraband Exercises in Intensive Care Patients

NCT06416540 | Completed

• 1 other identifier: ICU-THERABAND-35
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Exercise; Intensive Care Unit Patients

Keywords

Intensive Care Units; Exercise; Quality of Life; Physical Therapy Techniques

Outcome Measures

Primary Outcomes (12)

• 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.

  At baseline and on average day 10

• 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.

  At baseline and on average day 10

• 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.

  At baseline and on average day 10

• 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.

  At baseline and on average day 10

• 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.

  At baseline and on average day 10

• 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

  At baseline and on average day 10

• 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.

  At baseline and on average day 10

• 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.

  At baseline and on average day 10

• 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.

  At baseline and on average day 10

• Assessment of thoracic mobility

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

  At baseline and on average day 10

• 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.

  At baseline and on average day 10

• 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.

  At baseline and on average day 10

Study Arms (2)

Theraband Exercises plus Conventional Physiotherapy and Rehabilitation Group (TB+CPRG)

EXPERIMENTAL

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.

Other: Theraband Exercises plus Conventional Physiotherapy and Rehabilitation Program; Other: Conventional Physiotherapy and Rehabilitation Program

Conventional Physiotherapy and Rehabilitation Group (CPRG)

OTHER

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.

Other: Conventional Physiotherapy and Rehabilitation Program

Interventions

Theraband Exercises plus Conventional Physiotherapy and Rehabilitation Program OTHER

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.

Also known as: Theraband Exercises in ICU

Theraband Exercises plus Conventional Physiotherapy and Rehabilitation Group (TB+CPRG)

Conventional Physiotherapy and Rehabilitation Program OTHER

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.

Also known as: Control Group

Conventional Physiotherapy and Rehabilitation Group (CPRG); Theraband Exercises plus Conventional Physiotherapy and Rehabilitation Group (TB+CPRG)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Betül TAŞPINAR

Konak, İ̇zmi̇r, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Rehabilitation; Intensive Care Units; Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Hospital Units; Health Facilities; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Pınar Unde Ayvat, Assoc. Prof.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Ferruh Taspinar, Prof. Dr.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 16, 2024
• Study Start: May 21, 2024
• Primary Completion: July 22, 2024
• Study Completion: July 29, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

TU (1)