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NCT Number: NCT04783168

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Garrett L. Walsh

CONTACT

713-792-6849

Garrett L. Walsh

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • English speaking
  • Ambulatory preoperatively
  • Patients undergoing at least a lobectomy
  • Must own a smart phone and be willing to install the Fitbit application (App)
  • Adequate internet connection via wifi or wireless network connection with smartphone
  • Patients who are not already using a wearable device to track daily steps

Exclusion criteria

  • Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study.
  • Cannot maintain activity monitor in place at the time of consent
  • Pregnant patients

Treatment and study plan

Best Practice

Other

Receive usual care

Other names: standard of care, standard therapy

Health Promotion and Education

Other

Install and use Fitbit app

Medical Device Usage and Evaluation

Other

Use Fitbit to monitor step count

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Clavien-Dindo postoperative morbidity (POM) score

    Time frame: Up to 30 days after surgery

    Two Bayesian probability and inferential models will be utilized:

    • Model 1: Inferential goals: Probability that POM score in the control arm is greater than F0 or FB arm: mean and 95% Credible Interval
    • Model 2: Baseline covariates adjusted analysis of model 1
    • Performance status
    • FEV1
    • Age
    • Open vs. Minimally invasive (0 is best, 5 is worst.) 0 - No postoperative complications 1. - Minor complication resolved without intervention 2. - complication requiring pharmaceutical intervention 3. - complication requiring surgical, endoscopic or radiological intervention, 4. - life-threatening complication requiring intensive care 5. - complication leading to the patient's death.

Secondary outcomes

  1. Differences in steps regained at each postoperative day (Fitbit only arm [F0] and Fitbit integration arm [FB])

    Time frame: Up to 30 days after surgery

    Number of steps regained starting from after surgery for each of the arms.

  2. Change in quality of life

    Time frame: Baseline to 30 days after surgery

    Assessed using MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC). (0 - 10 discrete numbers) 0 - Not present 10 - As bad as you can imagine.

  3. Hospital length of stay

    Time frame: Up to 30 days after surgery

  4. Hospital readmission rate for lung surgery related events

    Time frame: Up to 30 days after surgery

  5. Return of bowel function

    Time frame: Up to 30 days after surgery

    Time to first bowel movement.

  6. Postoperative complications and step numbers

    Time frame: Up to 30 days after surgery

    How would you rate daily step goals as being helpful in your postoperative recovery? From 0-5, 0 being not helpful at all and 5 being the most helpful.

  7. Fitbit user experience (F0 and FB arm)

    Time frame: Up to 30 days after surgery

    Survey. How would you rate the use of Fitbit in your postoperative recovery From 0-5, 0 being not helpful at all and 5 being the most helpful How difficult was it to keep the device on your wrist From 0-5, 0 being extremely difficult, and 5 being extremely easy.

Study contacts

Contact information is provided by the study sponsor or research team.

Garrett L Walsh

CONTACT

[email protected]

713-792-6849

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

Ambulation to Improve Recovery With Wearable TECHnology (AIRTECH) Study

Acronym: AIRTECH

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Mar 5, 2021
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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