Geriatric Thoracic Surgery Ambulation Challenge
Pre-Operative Exercise Challenge In Geriatric Thoracic Patients
1 other identifier
interventional
30
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2020
CompletedFirst Posted
Study publicly available on registry
November 16, 2020
CompletedStudy Start
First participant enrolled
August 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedApril 13, 2025
April 1, 2025
4.3 years
November 13, 2020
April 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (1)
PRE-OPERATIVE EXERCISE TRACKING
EXPERIMENTALParticipant 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.
Interventions
Electronic activity tracker
Eligibility Criteria
You may qualify if:
- Patients Aged ≥ 65 years
- Who are preparing to undergo thoracic surgery at Brigham and Women's Hospital (BWH)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael T Jaklitsch, MD
Brigham and Women's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 13, 2020
First Posted
November 16, 2020
Study Start
August 25, 2021
Primary Completion
December 1, 2025
Study Completion
January 1, 2026
Last Updated
April 13, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
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.