Impact of Trimodal Prehabilitation on Perioperative Sleep: A Randomized Controlled Trial

JRCT ID: jRCT1052240186

Registered date:15/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Lung cancer
• Date of first enrollment: 15/11/2024
• Target sample size: 62
• Study type: Interventional

Intervention(s)

Intervention for the Experimental Group:
Exercise: Aiming for 5,000 steps per day and performing 30 handgrip exercises daily (using a distributed handgrip device for repetitive hand squeezing).
Nutrition: Adherence to dietary advice provided by a nutritionist and consumption of two cans of Isocal 200 per day.
Psychological Support: Implementation of relaxation techniques (such as progressive muscle relaxation, deep breathing exercises, meditation, aromatherapy, and music therapy) and addressing preoperative anxiety through online counseling sessions.

Outcome(s)

• Primary Outcome: sleep efficiency

Secondary Outcome

Sleep-related indicators (sleep onset latency, total sleep time, wake after sleep onset)
Postoperative recovery (measured using the Japanese version of the Quality of Recovery-15)
Postoperative delirium (assessed using the Confusion Assessment Method (CAM) on general wards and CAM-ICU in the intensive care unit)
Postoperative complications (evaluated using the Clavien-Dindo classification up to 30 days postoperatively)
Postoperative length of hospital stay
Functional status (assessed using the 12-item WHO Disability Assessment Schedule (WHODAS 2.0))

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients aged 20 and over
2) Lung cancer patients
3) Patients undergoing lobectomy with thoracoscopic assistance
4) Patients who can secure a period of 14 days or more from the decision to surgery

Exclude criteria

1) Patients who do not agree
2) Patients with stage 3 and IV (percent FEV1 less than 50 percent) chronic obstructive pulmonary disease
3) Patients undergoing home oxygen therapy
4) Patients with manual muscle strength measurement of 2 or less
5) Patients undergoing dialysis
6) Patients visiting a psychiatric clinic
7) Patients with inborn errors of metabolism
8) Patients with problems eating and swallowing
9) Patients who meet the following cancer rehabilitation discontinuation criteria
1. Blood findings: hemoglobin 7.5 g / dl or less, platelets 50,000 / ul or less, white blood cells 3,000 / ul or less
2. Findings of metastasis of long bones with invasion of 50 percent or more of the bone cortex, bone erosion toward the center of the bone, lesions of 3 cm or more of the femur, etc.
3. Compression of cavities, blood vessels, and spinal cord
4. Exudate retention in the pleura, peritoneum, and retroperitoneum due to pain, dyspnea, and restricted movement
5. Central nervous system dysfunction, impaired consciousness, increased intracranial pressure
6. Low / hyperkalemia, low / hypernatremia, low / hypercalcemia
7. Orthostatic hypotension, hypertension of 160 / 100 mmHg or higher
Tachycardia of
8. 110 / min or more, ventricular arrhythmia
10) Patients with diabetes and HbA1c greater than or equal to 8.4 percent
11) Patients with eGFR level under 45 ml / min / 1.73 square meters
12) Patients classified as Child-Pugh Class C (Coma state 3 or above due to hepatic encephalopathy, moderate or greater ascites, serum bilirubin level exceeding 3.0 mg / dl, serum albumin level below 2.8 g / dl, prothrombin time activity level under 40 percent, international normalize ratio (INR) over 2.3)

Related Information

• Primary Sponsor: Ida Mitsuru
• Source(s) of Monetary Support: Kakenhi