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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1052240186
Enrollment
62
Registered
2024-11-15
Start date
2024-11-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer Malignancy

Interventions

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). Nutrit
Prehabilitation

Sponsors

Ida Mitsuru
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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)

Design outcomes

Primary

MeasureTime frame
sleep efficiency

Secondary

MeasureTime frame
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))

Contacts

Public ContactMariko Sato

Nara Medical University

K153699@naramed-u.ac.jp+81-744-29-8902

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026