Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04783168
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2021-02-03
Brief Title:
Walking After Surgery to Improve Recovery and Outcomes After Surgery AIRTECH Study
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Ambulation to Improve Recovery With Wearable TECHnology AIRTECH Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIRTECH
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
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 HRTM 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
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 HRTM 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-0453 | OTHER | M D Anderson Cancer Center | None |
| NCI-2020-14126 | REGISTRY | None | None |