Walking After Surgery to Improve Recovery and Outcomes After Surgery, AIRTECH Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Best Practice, Health Promotion and Education, Medical Device Usage and Evaluation, Quality-of-Life Assessment.
- Who it may be relevant to
- Registry conditions: Lung Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ambulation to Improve Recovery With Wearable TECHnology (AIRTECH) Study
Overview
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.
Interventions
- 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
Primary outcome measures
- Clavien-Dindo postoperative morbidity (POM) score [Time frame: Up to 30 days after surgery]
Secondary outcome measures (7)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT04783168 · 2020-0453 · NCI-2020-14126 · 2020-0453