Geriatric Thoracic Surgery Ambulation Challenge
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fitbit.
- Who it may be relevant to
- Registry conditions: Thoracic Diseases, Surgery, Therapy, Exercise. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pre-Operative Exercise Challenge In Geriatric Thoracic Patients
Overview
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.
Interventions
- Behavioral Fitbit
Electronic activity tracker
Primary outcome measures
- Step Tracking Rate [Time frame: 1 week]
- Diary of Steps Rate [Time frame: 1 week]
- Return Rate [Time frame: 1 week]
- Data Retrieval Rate [Time frame: 1 week]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Brigham and Women's Hospital — Boston
- Dana-Farber Cancer Institute — Boston
Identifiers
NCT: NCT04630496 · 20-061