Clinical trial NCT04630496: Geriatric Thoracic Surgery Ambulation Challenge
Official title: Pre-Operative Exercise Challenge In Geriatric Thoracic Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracic Diseases
Surgery
Therapy, Exercise
Keywords: Thoracic Diseases
Lung Resection
Perioperative activity
Pedometer tracker
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is examining collecting data on steps walked (ambulation) per day by thoracic surgery patients over the age of 65 years-old before surgery.

The name(s) of the study device involved in this study is:

* Fitbit inspire

Detailed description: This research study is a Feasibility Study, which is the first-time investigators are examining the use of a Fitbit by thoracic surgery patients over the age of 65 years-old before surgery. The study is looking to see if patients can wear a wrist step-tracker and keep a log of their daily step counts for one week. The study is looking to see if people are willing to keep track of their daily steps, so in the future participants may be provided with step-goals to achieve and their steps prior to surgery can be accurately measured.

This research study involves using a Fitbit tracker to record daily steps over the course of 1 week prior to scheduled surgery. Participants will be given a step tracker in clinic and instructed on its use. During the 1 week period, participants will be called by a study team to check on progress.

After a week, participants will be asked to return the step-tracker and their log either at a scheduled pre-surgery clinic visit or in the pre-operative area which ever comes first.

It is expected that about 30 people will take part in this research study.

Eligibility criteria: Inclusion Criteria:

* Patients Aged ≥ 65 years

  * Who are preparing to undergo thoracic surgery at Brigham and Women's Hospital (BWH)

Exclusion Criteria:

* Patients who are completely non-ambulatory (i.e. wheelchair-bound-patients) \*
* Those who lack capacity to consent due to cognitive disease.
* Patient for which surgery is felt to be more urgent and therefore performed earlier then our required timeframe for intervention.
* Patients with cardiac disease or angina for which formal cardiac testing is required for clearance.

  * Our exclusion criteria do not include patients with gait disturbances or those who require assistance devices for ambulation.

Primary outcomes:
measure: Step Tracking Rate
timeFrame: 1 week
measure: Diary of Steps Rate
timeFrame: 1 week
measure: Return Rate
timeFrame: 1 week
measure: Data Retrieval Rate
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Michael T Jaklitsch, MD
role: PRINCIPAL_INVESTIGATOR
References: