NCT02522533

Brief Summary

Frailty has been associated with poor acute and long-term outcomes after major surgery. We recently determined that nearly 70% of patients undergoing major thoracic surgery are pre-frail or frail. We are interested in assessing whether a strength training intervention for frail or pre-frail patients has an impact on surgical decision making and on surgical outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2017

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

2.2 years

First QC Date

August 3, 2015

Last Update Submit

April 24, 2023

Conditions

Frailty

Outcome Measures

Primary Outcomes (1)

  • Reduction in the degree of frailty after strength training

    18 months

Secondary Outcomes (1)

  • Changes in surgeon risk assessment after strength training

    18 months

Study Arms (1)

Physical Therapy

EXPERIMENTAL

Patients will be receiving 6 weeks of an exercise program.

Other: Physical Therapy

Interventions

Physical TherapyOTHER

6 weeks of an exercise program.

Physical Therapy

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Frailty

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Mark Ferguson, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 13, 2015

Study Start

July 20, 2015

Primary Completion

October 16, 2017

Study Completion

October 16, 2017

Last Updated

April 26, 2023

Record last verified: 2023-04

Locations

US(1)