Geriatric Thoracic Surgery Ambulation Challenge

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04630496
Collaborator
(none)
30
2
1
17
15
0.9

Study Details

Study Description

Brief Summary

This study is examining collecting data on steps walked (ambulation) per day by thoracic surgery patients over the age of 70 years-old before surgery.

The name(s) of the study device involved in this study is:
  • Fitbit inspire
Condition or Disease Intervention/Treatment Phase
  • Behavioral: Fitbit
N/A

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 70 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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Pre-Operative Exercise Challenge In Geriatric Thoracic Patients
Actual Study Start Date :
Aug 25, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jan 23, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Step Tracking Rate [1 week]

      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

    2. Diary of Steps Rate [1 week]

      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.

    3. Return Rate [1 week]

      If 90% of trackers are returned, it will be considered a successful return.

    4. Data Retrieval Rate [1 week]

      assess extraction of the data from the mobility upon return. Success will be considered if 90% of data is retrievable

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    70 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients Aged ≥ 70 years

    • Who are preparing to undergo lung resection of the magnitude of wedge resection or greater (segmentectomy, lobectomy, bilobectomy, or pneumonectomy) 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brigham and Women's Hospital Boston Massachusetts United States 02115
    2 Dana-Farber Cancer Institute Boston Massachusetts United States 02215

    Sponsors and Collaborators

    • Dana-Farber Cancer Institute

    Investigators

    • Principal Investigator: Michael T Jaklitsch, MD, Brigham and Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael T. Jaklitsch, Principal Investigator, Dana-Farber Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT04630496
    Other Study ID Numbers:
    • 20-061
    First Posted:
    Nov 16, 2020
    Last Update Posted:
    Apr 8, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Michael T. Jaklitsch, Principal Investigator, Dana-Farber Cancer Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 8, 2022