Thoracic DiseasesNCT04630496
Geriatric Thoracic Surgery Ambulation Challenge
A study testing Fitbit in people with Thoracic Diseases and Surgery, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Thoracic Diseases, Surgery, Therapy, Exercise
- What is being tested?
- Fitbit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Aug 2021to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients Aged ≥ 65 years
- Who are preparing to undergo thoracic surgery at Brigham and Women's Hospital (BWH)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Michael Jaklitsch, MD, 617-732- 6988, mjaklitsch@bwh.harvard.edu
Michael Jaklitsch, MD
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Michael T Jaklitsch, MD, 617-732- 6988, mjaklitsch@bwh.harvard.edu
Michael T Jaklitsch, MD
About this study
Official title: Pre-Operative Exercise Challenge In Geriatric Thoracic Patients
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
Read the 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.
- Conditions
- Thoracic Diseases, Surgery, Therapy, Exercise
- Being tested
- Fitbit
- Keywords
- Thoracic Diseases, Lung Resection, Perioperative activity, Pedometer tracker
- Medical subject headings
- Thoracic Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitbitBehavioural
Also called mobility tracker, pedometer
Electronic activity tracker
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Fitbit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 1 week
Return Rate
If 90% of trackers are returned, it will be considered a successful return.
Measured: 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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start25 Aug 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic DiseasesStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Jaklitsch, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Michael T Jaklitsch, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630496
- Sponsor's protocol ID
- 20-061
- Status last verified
- Apr 2025
- First submitted
- 13 Nov 2020
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Operative Exercise Challenge In Geriatric Thoracic Patients
- ClinicalTrials.gov ID
- NCT04630496
- Acronym / sponsor ID
- 20-061
- Conditions
- Thoracic Diseases, Surgery, Therapy, Exercise
- Keywords
- Thoracic Diseases, Lung Resection, Perioperative activity, Pedometer tracker
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRE-OPERATIVE EXERCISE TRACKING | Experimental | Behavioral: FitbitParticipant 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients Aged ≥ 65 years
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitbitAlso: mobility tracker, pedometerElectronic activity tracker | Behavioural | PRE-OPERATIVE EXERCISE TRACKING |
Primary outcome
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
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.
Return Rate
Time frame: 1 week
If 90% of trackers are returned, it will be considered a successful return.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael T Jaklitsch, MD principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit in people with Thoracic Diseases and Surgery, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael T Jaklitsch, MD (617-732- 6988, mjaklitsch@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step Tracking Rate (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.