Wireless Wearable Home Prehabilitation for Older Adults With NSCLC

Forced expiratory volume in 1 second as a percentage of the predicted value, measured by spirometry according to ATS/ERS standards. The measurement is taken at the 90-day (±14 days) follow-up visit. The primary analysis compares the adjusted between-grou

Forced vital capacity measured by spirometry according to ATS/ERS standards and expressed as a percentage of the predicted value. Change from the preoperative baseline value will be determined at 30 and 90 days after surgery.

The ratio of forced expiratory volume in 1 second to forced vital capacity, measured by spirometry according to ATS/ERS standards. Change from the preoperative baseline value will be determined at 30 and 90 days after surgery.

Distance walked during a 6-minute walk test performed on a flat, marked course according to ATS guidelines. Change from the preoperative baseline distance will be determined at 30 and 90 days after surgery.

Borg dyspnea scores will be recorded immediately before and immediately after each 6-minute walk test. The outcome is calculated as the post-test score minus the pre-test score.

The mean number of steps per day recorded by the wearable device. For the intervention group, step count will be recorded throughout the intervention period. For the control group, step count will be recorded during protocol-specified 7-day assessment periods. Daily values will be averaged across valid wear days, defined as days with at least 10 hours of wear time.

The mean duration of moderate-to-vigorous physical activity recorded by the wearable device. For the intervention group, activity will be recorded throughout the intervention period. For the control group, activity will be recorded during protocol-specified 7-day assessment periods. Values will be averaged across valid wear days, defined as days with at least 10 hours of wear time.

The percentage of valid pulse-oximetry monitoring time during which peripheral oxygen saturation is below 90%, calculated from continuous or minute-level SpO2 recordings.

The mean number of nocturnal oxygen desaturation events per hour of valid overnight recording. An oxygen desaturation event is defined as a decrease in SpO2 of at least 3% from the preceding baseline level.

Health-related quality of life assessed using the EORTC QLQ-C30 Global Health Status/Quality of Life scale. Scores are transformed to a 0-100 scale according to the EORTC scoring manual, with higher scores indicating better global health status and quality of life. Change from the preoperative baseline score will be determined at 30 and 90 days after surgery.

Lung cancer-related symptoms assessed using the prespecified EORTC QLQ-LC13 scale or item. Scores will be calculated according to the EORTC scoring manual and transformed to a 0-100 scale. Change from the preoperative baseline score will be determined at 30 and 90 days after surgery. The direction of a higher score should be stated for the selected scale or item.

Dyspnea assessed using the modified Medical Research Council scale, ranging from 0 to 4, with higher scores indicating greater dyspnea-related functional limitation. Change from the preoperative baseline score will be determined at 30 and 90 days after surgery.

Percentage of participants who have at least one unplanned hospital readmission for any cause during the first 90 days after surgery.

Percentage of participants who have at least one emergency department visit for any cause during the first 90 days after surgery.

Percentage of participants who experience at least one postoperative pulmonary complication meeting the protocol-specified EPCO or CHEST criteria. Pulmonary complications include pneumonia, respiratory failure or re-intubation, atelectasis requiring intervention, acute respiratory distress syndrome, pleural effusion requiring drainage, bronchospasm requiring treatment, or pulmonary embolism. Each participant will be counted once regardless of the number of complications experienced.

Number of days during the first 90 postoperative days that the participant is alive and not admitted to a hospital, rehabilitation facility, or other inpatient institutional care facility. The value is calculated as 90 minus the total number of days spent in hospital or institutional care. Participants who die within 90 days after surgery will be assigned a value of zero days.

Percentage of participants who experience at least one adverse event after providing informed consent. Adverse events will be identified and graded according to CTCAE version 5.0. Events of special interest include exercise-related, wearable-device-related, and oxygen-related adverse events. Each participant will be counted once regardless of the number of adverse events experienced.

Percentage of participants who experience at least one serious adverse event after providing informed consent. Serious adverse events will be classified and graded according to the protocol and CTCAE version 5.0. Each participant will be counted once regardless of the number of serious adverse events experienced.

Percentage of observed days on which the wearable device is worn for at least 12 hours. The numerator is the number of days meeting the required wear-time threshold, and the denominator is the total number of expected observation days.

Percentage of prescribed exercise sessions completed by participants in the intervention group. The numerator is the number of completed prescribed sessions, and the denominator is the total number of prescribed sessions during the intervention period.