NCT04783168

Walking After Surgery to Improve Recovery and Outcomes After Surgery, AIRTECH Study

Ambulation to Improve Recovery With Wearable TECHnology (AIRTECH) Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial evaluates the relationship between walking and sleeping habits and surgical outcomes in patients with lung cancer. Early walking after surgery is associated with decreased or less severe complications. Learning about how much patients walk may be important in improving outcomes after surgery. Information gained from this trial may help researchers develop interventions to improve outcomes after surgery and improve overall quality of life after surgery in patients with lung cancer.

Detailed description

PRIMARY OBJECTIVE: I. Estimate the difference between each Fitbit arm and a control arm in Clavien-Dindo Combined Postoperative Morbidity (POM) Score in the 30-day postoperative period. SECONDARY OBJECTIVES: I. For patients in Fitbit only arm (F0) and Fitbit integration arm (FB), evaluate the differences in steps regained at each postoperative day. II. Quality of life before and after surgery using MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC). III. Hospital length of stay. IV. Hospital readmission rate within 30 days for lung surgery related events. V. Return of bowel function. VI. Postoperative complications and step numbers. VII. Fitbit user experience in the FB arm. EXPLORATORY OBJECTIVES: I. Sleep disturbances. II. Cost analysis. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and early ambulation in the postoperative setting. ARM II: Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and early ambulation in the postoperative setting. Patients also receive a Fitbit to monitor step count. ARM III: Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and walking in the postoperative setting. Patients also receive a Fitbit device install and use the Fitbit app on a smartphone. Postoperative step goals are as follows: Postoperative day (POD) 1: 25% of baseline. Subsequent days will be increased by 10% until patient reaches baseline daily step number. Five automatic daily reminders (delivered by the Fitbit Inspire HR\^TM device itself) to meet a minimum of 250 steps an hour. Postoperatively, patients will be invited to participate in a private group with a leaderboard that consists of step numbers of other participants in the study in an anonymous fashion. After completion of study intervention, patients are followed up at postoperative clinic and at 30 days after surgery.

Conditions

• Lung Carcinoma

Interventions

Type	Name	Description
OTHER	Best Practice	Receive usual care
OTHER	Health Promotion and Education	Install and use Fitbit app
OTHER	Medical Device Usage and Evaluation	Use Fitbit to monitor step count
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2020-11-30
• Primary completion: 2027-02-02
• Completion: 2027-02-02
• First posted: 2021-03-05
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States