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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRE-OPERATIVE EXERCISE TRACKING | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitbit | Behavioral | Electronic activity tracker |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Patients Aged ≥ 65 years
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael T Jaklitsch, MD | Contact | 617-732- 6988 | mjaklitsch@bwh.harvard.edu | |
| Anupama Singh, MD | Contact | 781-492-5807 | asingh54@bwh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael T Jaklitsch, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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| ID | Term |
|---|---|
| D013896 | Thoracic Diseases |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
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| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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