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Geriatric Thoracic Surgery Ambulation Challenge

Primary Purpose

Thoracic Diseases, Surgery, Therapy, Exercise

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fitbit
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thoracic Diseases focused on measuring Thoracic Diseases, Lung Resection, Perioperative activity, Pedometer tracker

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brigham and Women's HospitalRecruiting
  • Dana-Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRE-OPERATIVE EXERCISE TRACKING

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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.
Return Rate
If 90% of trackers are returned, it will be considered a successful return.
Data Retrieval Rate
assess extraction of the data from the mobility upon return. Success will be considered if 90% of data is retrievable

Secondary Outcome Measures

Full Information

First Posted
November 13, 2020
Last Updated
February 13, 2023
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04630496
Brief Title
Geriatric Thoracic Surgery Ambulation Challenge
Official Title
Pre-Operative Exercise Challenge In Geriatric Thoracic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2021 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Diseases, Surgery, Therapy, Exercise
Keywords
Thoracic Diseases, Lung Resection, Perioperative activity, Pedometer tracker

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRE-OPERATIVE EXERCISE TRACKING
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Fitbit
Other Intervention Name(s)
mobility tracker, pedometer
Intervention Description
Electronic activity tracker
Primary Outcome Measure Information:
Title
Step Tracking Rate
Description
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
Time Frame
1 week
Title
Diary of Steps Rate
Description
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.
Time Frame
1 week
Title
Return Rate
Description
If 90% of trackers are returned, it will be considered a successful return.
Time Frame
1 week
Title
Data Retrieval Rate
Description
assess extraction of the data from the mobility upon return. Success will be considered if 90% of data is retrievable
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients Aged ≥ 65 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael T Jaklitsch, MD
Phone
617-732- 6988
Email
mjaklitsch@bwh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Anupama Singh, MD
Phone
781-492-5807
Email
asingh54@bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael T Jaklitsch, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Jaklitsch, MD
Phone
617-732-6988
Email
mjaklitsch@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Michael Jaklitsch, MD
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael T Jaklitsch, MD
Phone
617-732-6988
Email
mjaklitsch@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Michael T Jaklitsch, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Geriatric Thoracic Surgery Ambulation Challenge

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