Geriatric Thoracic Surgery Ambulation Challenge

Pre-Operative Exercise Challenge In Geriatric Thoracic Patients

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

Study Overview

• Status: Recruiting
• Conditions: Surgery; Thoracic Diseases; Therapy, Exercise
• Intervention / Treatment: Behavioral: Fitbit

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael T Jaklitsch, MD; Phone Number: 617-732- 6988; Email: mjaklitsch@bwh.harvard.edu
• Study Contact Backup: Name: Anupama Singh, MD; Phone Number: 781-492-5807; Email: asingh54@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Michael Jaklitsch, MD; Phone Number: 617-732-6988; Email: mjaklitsch@bwh.harvard.edu
      • Principal Investigator: Michael Jaklitsch, MD
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Michael T Jaklitsch, MD; Phone Number: 617-732-6988; Email: mjaklitsch@bwh.harvard.edu
      • Principal Investigator: Michael T Jaklitsch, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PRE-OPERATIVE EXERCISE TRACKING; Participant baseline information will be collected from their electronic medical records. After enrollment, participants will be provided a mobile device (Fitbit) to wear for tracking steps for 1 week prior to their scheduled surgery. Participants will keep a log of daily steps for the 1 week they are wearing the device and receive one progress check-in call during the week. The device and log will be turned in either on a pre-surgery clinic visit or on the day of surgery whichever comes first.

Behavioral: Fitbit; Electronic activity tracker; Other Names: mobility tracker; pedometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Return Rate	If 90% of trackers are returned, it will be considered a successful return.	1 week
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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Michael T Jaklitsch, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 23, 2024

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Lung Resection; Thoracic Diseases; Perioperative activity; Pedometer tracker
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Thoracic Diseases
• Other Study ID Numbers: 20-061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No