Geriatric Thoracic Surgery Ambulation Challenge

Surgery Clinical Trial

Official title:

Pre-Operative Exercise Challenge In Geriatric Thoracic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04630496
• Other study ID #: 20-061
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2021
• Est. completion date: December 23, 2024

Study information

• Verified date: February 2024
• Source: Dana-Farber Cancer Institute
• Contact: Michael T Jaklitsch, MD
• Phone: 617-732- 6988
• Email: mjaklitsch[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 23, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Surgery
• Therapy, Exercise
• Thoracic Diseases

Intervention

Behavioral:
• Fitbit
Electronic activity tracker

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Step Tracking Rate	Feasibility will be determined by the successful tracking of steps and keeping a diary of step-count for one-week duration. Completion of a minimum of 5/7 days will be considered as a success	1 week
Primary	Diary of Steps Rate	Feasibility will be determined by the successful tracking of steps and keeping a diary of step-count for one-week duration. We will consider completion of a minimum of 5/7 days as a success.	1 week
Primary	Return Rate	If 90% of trackers are returned, it will be considered a successful return.	1 week
Primary	Data Retrieval Rate	assess extraction of the data from the mobility upon return. Success will be considered if 90% of data is retrievable	1 week