Lung CarcinomaAIRTECHNCT04783168
Walking After Surgery to Improve Recovery and Outcomes After Surgery, AIRTECH Study
A study testing Best Practice, Health Promotion and Education and Medical Device Usage and Evaluation in people with Lung Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Carcinoma
- What is being tested?
- Best Practice, Health Promotion and Education and Medical Device Usage and Evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2020to 2 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Garrett L. Walsh, 713-792-6849
Garrett L. Walsh
About this study
Official title: Ambulation to Improve Recovery With Wearable TECHnology (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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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
- Being tested
- Best Practice, Health Promotion and Education, Medical Device Usage and Evaluation, Quality-of-Life Assessment, Questionnaire Administration
- Keywords
- Wearable, device, fitness, tracker, Fitbit, ambulation, lung cancer, surgical, recovery
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Health Promotion and EducationOther
Install and use Fitbit app
Medical Device Usage and EvaluationOther
Use Fitbit to monitor step count
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Other: Best Practice; Other: Health Promotion and Education; Other: Medical Device Usage and Evaluation; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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])
Number of steps regained starting from after surgery for each of the arms.
Measured: Up to 30 days after surgery
Change in quality of life
Assessed using MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC). (0 - 10 discrete numbers) 0 - Not present 10 - As bad as you can imagine.
Measured: Baseline to 30 days after surgery
Hospital length of stay
Measured: Up to 30 days after surgery
Hospital readmission rate for lung surgery related events
Measured: Up to 30 days after surgery
Return of bowel function
Time to first bowel movement.
Measured: Up to 30 days after surgery
Postoperative complications and step numbers
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.
Measured: Up to 30 days after surgery
Fitbit user experience (F0 and FB arm)
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.
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start30 Nov 2020
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Garrett L Walsh, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783168
- Sponsor's protocol ID
- 2020-0453
- Other IDs
- NCI-2020-14126, 2020-0453
- Acronym
- AIRTECH
- Status last verified
- Oct 2026
- First submitted
- 3 Feb 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulation to Improve Recovery With Wearable TECHnology (AIRTECH) Study
- ClinicalTrials.gov ID
- NCT04783168
- Acronym / sponsor ID
- AIRTECH / 2020-0453
- Conditions
- Lung Carcinoma
- Keywords
- Wearable, device, fitness, tracker, Fitbit, ambulation, lung cancer, surgical
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (usual care) | Active comparator | Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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 (usual care, Fitbit) | Active comparator | Other: Best Practice, Other: Medical Device Usage and Evaluation, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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 (usual care, Fitbit, Fitbit app) | Experimental | Other: Best Practice, Other: Health Promotion and Education, Other: Medical Device Usage and Evaluation, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Arm I (usual care), Arm II (usual care, Fitbit), Arm III (usual care, Fitbit, Fitbit app) |
| Health Promotion and EducationInstall and use Fitbit app | Other | Arm III (usual care, Fitbit, Fitbit app) |
| Medical Device Usage and EvaluationUse Fitbit to monitor step count | Other | Arm II (usual care, Fitbit), Arm III (usual care, Fitbit, Fitbit app) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (usual care), Arm II (usual care, Fitbit), Arm III (usual care, Fitbit, Fitbit app) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (usual care), Arm II (usual care, Fitbit), Arm III (usual care, Fitbit, Fitbit app) |
Primary outcome
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.
7 secondary outcomes
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
Change in quality of life
Time frame: Baseline to 30 days after surgery
Hospital length of stay
Time frame: Up to 30 days after surgery
Hospital readmission rate for lung surgery related events
Time frame: Up to 30 days after surgery
Return of bowel function
Time frame: Up to 30 days after surgery
Postoperative complications and step numbers
Time frame: Up to 30 days after surgery
Fitbit user experience (F0 and FB arm)
Time frame: Up to 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Garrett L Walsh principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Health Promotion and Education and Medical Device Usage and Evaluation in people with Lung Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Garrett L Walsh (713-792-6849, gwalsh@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clavien-Dindo postoperative morbidity (POM) score (time frame: Up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.