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CompletedNCT02522533Updated Apr 26, 2023

Intervention for Pre-Frailty and Frailty in Thoracic Surgery Patients

An interventional study of Physical Therapy in Frailty, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-04-26.

Sponsored by University of Chicago · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
60 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Frailty

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In context

Frailty

1,199 studies on the registry are indexed under Frailty; 430 are open to participants now.

This study's enrollment of 7 is below the median of 80 across 681 interventional studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: • Age ≥60 years, • Qualified to consent for participation in a research study, •Thoracic disease that may require major surgery (major anatomic lung resection, esophagectomy, repair of giant paraesophageal hernia, chest wall resection, extended pleurectomy/decortication, thymectomy or major surgery for other mediastinal process),• No obvious contraindications to surgery (end-stage heart disease, end-stage lung disease, severe dementia, other specific comorbidity that would prevent surgery), • Ability to participate in physical therapy and an independent exercise program for frailty mitigation, •No need for induction chemotherapy or radiation therapy, • Recent evaluation including computed tomography of the chest or chest/abdomen.

Exclusion Criteria:• Age \<60 years, •Unable to provide informed consent, • No indication for major thoracic surgery, •Obvious contraindication to major thoracic surgery (end-stage heart disease, end-stage lung disease, severe dementia, other specific comorbidity that would preclude surgery),• Inability to participate in physical therapy and/or an independent home exercise for frailty mitigation, •Need for induction chemotherapy or radiation therapy

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Physical Therapy

    Patients will be receiving 6 weeks of an exercise program.

    Other: Physical Therapy

Interventions

  • OtherPhysical Therapy

    6 weeks of an exercise program.

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What researchers measure

Primary outcomes

  1. Reduction in the degree of frailty after strength training

    Time frame: 18 months

Secondary outcomes

  1. Changes in surgeon risk assessment after strength training

    Time frame: 18 months

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Study locations

1 site
  • University of Chicago
    Chicago, Illinois 60637, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02522533
Lead sponsor
University of Chicago
Responsible party
Sponsor
First posted
Aug 13, 2015
Start date
Jul 20, 2015
Primary completion
Oct 16, 2017
Completion
Oct 16, 2017
Last update
Apr 26, 2023

Study contacts

Mark Ferguson, MD
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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