Geriatric Thoracic Surgery Ambulation Challenge

NCT ID: NCT04630496

Last Updated: 2025-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-25

Study Completion Date

2026-01-01

Brief Summary

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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

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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.

Conditions

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Thoracic Diseases Surgery Therapy, Exercise

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Fitbit

Intervention Type BEHAVIORAL

Electronic activity tracker

Interventions

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Fitbit

Electronic activity tracker

Intervention Type BEHAVIORAL

Other Intervention Names

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mobility tracker pedometer

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Michael Jaklitsch, MD, MPH

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael T Jaklitsch, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael T Jaklitsch, MD

Role: CONTACT

617-732- 6988

Anupama Singh, MD

Role: CONTACT

781-492-5807

Facility Contacts

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Michael Jaklitsch, MD

Role: primary

617-732- 6988

Michael T Jaklitsch, MD

Role: primary

617-732- 6988

Other Identifiers

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20-061

Identifier Type: -

Identifier Source: org_study_id

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