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

NCT04783168 | Recruiting

• 2 other identifiers: 2020-0453NCI-2020-14126
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Carcinoma

Keywords

Wearable; device; fitness; tracker; Fitbit; ambulation; lung cancer; surgical; recovery

Outcome Measures

Primary Outcomes (1)

• Clavien-Dindo postoperative morbidity (POM) score

  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.

  Up to 30 days after surgery

Secondary Outcomes (7)

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

  Up to 30 days after surgery

• Change in quality of life

  Baseline to 30 days after surgery

• Hospital length of stay

  Up to 30 days after surgery

• Hospital readmission rate for lung surgery related events

  Up to 30 days after surgery

• Return of bowel function

  Up to 30 days after surgery

Study Arms (3)

Arm I (usual care)

ACTIVE COMPARATOR

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.

Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (usual care, Fitbit)

ACTIVE COMPARATOR

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

Other: Best Practice; Other: Medical Device Usage and Evaluation; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm III (usual care, Fitbit, Fitbit app)

EXPERIMENTAL

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.

Other: Best Practice; Other: Health Promotion and Education; Other: Medical Device Usage and Evaluation; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm I (usual care); Arm II (usual care, Fitbit); Arm III (usual care, Fitbit, Fitbit app)

Health Promotion and Education OTHER

Install and use Fitbit app

Arm III (usual care, Fitbit, Fitbit app)

Medical Device Usage and Evaluation OTHER

Use Fitbit to monitor step count

Arm II (usual care, Fitbit); Arm III (usual care, Fitbit, Fitbit app)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (usual care); Arm II (usual care, Fitbit); Arm III (usual care, Fitbit, Fitbit app)

Questionnaire Administration OTHER

Ancillary studies

Arm I (usual care); Arm II (usual care, Fitbit); Arm III (usual care, Fitbit, Fitbit app)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Health Promotion; Educational Status

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics

Study Officials

• Garrett L Walsh

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Garrett L Walsh

CONTACT

713-792-6849; gwalsh@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: March 5, 2021
• Study Start: November 30, 2020
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)