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NCT Number: NCT04630496

Geriatric Thoracic Surgery Ambulation Challenge

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

Recruiting

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fitbit

Behavioral

Electronic activity tracker

Other names: mobility tracker, pedometer

Primary outcomes

  1. Step Tracking Rate

    Time frame: 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

    Time frame: 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

    Time frame: 1 week

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

  4. Data Retrieval Rate

    Time frame: 1 week

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

Study contacts

Contact information is provided by the study sponsor or research team.

Anupama Singh, MD

CONTACT

[email protected]

781-492-5807

Michael T Jaklitsch, MD

CONTACT

[email protected]

617-732- 6988

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

Pre-Operative Exercise Challenge In Geriatric Thoracic Patients

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Nov 16, 2020
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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