Post-Operative Ambulatory Challenge and Exercise (PACE) Trial
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cancer
Started Aug 2017
Typical duration for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2017
CompletedFirst Posted
Study publicly available on registry
August 1, 2017
CompletedStudy Start
First participant enrolled
August 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedApril 3, 2020
April 1, 2020
2.7 years
July 27, 2017
April 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Steps Taken
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.
2 years
Secondary Outcomes (2)
Distance walked
2 years
Number of Calories Burned
2 years
Study Arms (1)
Mobility Tracker
EXPERIMENTAL* 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with baseline immobility (i.e. wheelchair-bound, use of any walking assistance device, or gait alterations)
- Patients with cognitive deficits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Michael T Jaklitsch, MD
Brigham and Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Michael Jaklitsch, MD
Study Record Dates
First Submitted
July 27, 2017
First Posted
August 1, 2017
Study Start
August 2, 2017
Primary Completion
April 1, 2020
Study Completion
April 1, 2020
Last Updated
April 3, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share