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Post-Operative Ambulatory Challenge and Exercise (PACE) Trial

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ClinicalTrials.gov Identifier: NCT03234933
Recruitment Status : Recruiting
First Posted : August 1, 2017
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Michael T. Jaklitsch, Dana-Farber Cancer Institute

Brief Summary:
This research study is evaluating the postoperative results in terms of quality of life and functional recovery of elderly patients after cancer surgery.

Condition or disease Intervention/treatment Phase
Cancer Device: Mobility Tracker Not Applicable

Detailed Description:
This is a pilot study, designed to collect data on steps walked (ambulation) per day of lobectomy patients after surgery. While the investigators know ambulation improves outcomes after surgery, there is no institutional policy, set of patient goals, or method for deciding which patients require further resources, such as physical therapy. Data collected will be used to set up a hospital-wide strategy for patients to achieve post-operative ambulation milestones more readily.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Post-Operative Ambulatory Challenge and Exercise (PACE) Trial
Actual Study Start Date : August 2, 2017
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2023

Arm Intervention/treatment
Experimental: Mobility Tracker
  • Each patient will be provided by the research team staff with a new mobility tracker
  • The standard pre-operative assessment, surgical procedure and post-operative care will still be done
  • Measurements of each patient (steps, distance and calories) will be obtained by the research staff
Device: Mobility Tracker
Tracking Patient's movements and calories




Primary Outcome Measures :
  1. Number of Steps Taken [ Time Frame: 2 years ]
    Number of steps taken by subjects will be recorded on a mobility tracker, starting at the time of admission to the floor and ending at the time of discharge.


Secondary Outcome Measures :
  1. Distance walked [ Time Frame: 2 years ]
    The distance walked by subjects will be recorded on a mobility tracker, starting at the time of admission to the floor and ending at the time of discharge.

  2. Number of Calories Burned [ Time Frame: 2 years ]
    The number of calories burned by subjects will be recorded on a mobility tracker, starting at the time of admission to the floor and ending at the time of discharge.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients Aged ≥ 18 years
  • Who underwent or who will undergo lung resection at Brigham and Women's Hospital (BWH)
  • With diagnosis of malignant or benign disease

Exclusion Criteria:

  • Patients with baseline immobility (i.e. wheelchair-bound, use of any walking assistance device, or gait alterations)
  • Patients with cognitive deficits

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234933


Contacts
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Contact: Sam Fox 617-525-8541 sfox6@bwh.harvard.edu
Contact: Carlos Bravo, MD 617-732-6455 cbravoiniguez@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Carlos Bravos Iniguez    617-732-6455      
Principal Investigator: Michael T Jaklitsch, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Michael T Jaklitsch, MD Brigham and Women's Hospital

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Responsible Party: Michael T. Jaklitsch, Michael Jaklitsch, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03234933     History of Changes
Other Study ID Numbers: 17-152
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Keywords provided by Michael T. Jaklitsch, Dana-Farber Cancer Institute:
Cancer