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Exercise and Mortality in Middle-Aged and Older Adults

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City of Hope

Status

Begins enrollment in 1 month

Conditions

Overall Survival (All-cause Mortality)

Treatments

Behavioral: Control
Behavioral: Exercise

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

This protocol is a retrospective study using the observational data of the the Prostate, Lung, Colorectal, and Ovarian (PLCO) screening trial with over 150,000 participants aged 55-74 years to conduct a target trial emulation to examine the association between self-reported exercise and all cause and cause-specific mortality in apparently healthy, middle-aged and older adults. The PLCO includes assessments of participants' exercise level at two timepoints: at randomization into the PLCO trial (Q0) and 5-7 years after randomization into the PLCO (Q1).

Enrollment

19,000 estimated patients

Sex

All

Ages

55 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

  • Adults enrolled into the PLCO screening trial.
  • Among participants reporting low exercise at Q0 (i.e., 0 or less than 1 day/week, with each session <15 minutes in duration), completion of an exercise survey at Q1 as part of PLCO standard trial procedures no later than 5 years after reporting non-exercising status [i.e., no exercise) at Q0.
  • No evidence of any of the following absolute contraindications to exercise: uncontrolled hypertension, symptomatic valvular disease; hypertrophic cardiomyopathy; unstable angina pectoris; primary pulmonary hypertension; heart failure; severe arrhythmia; diagnosed dementia; any form of cancer other than non-melanoma, and severe infectious disease.

Trial design

19,000 participants in 2 patient groups

Arm 1 - Control
Description:
0 or less than 1 day per week, with each session, on average \< 15 minutes.
Treatment:
Behavioral: Control
Arm 2 - Exercise
Description:
\>/= 2 days per week of moderate or vigorous intensity, with each session, on average, \>/=20 minutes in duration.
Treatment:
Behavioral: Exercise

Trial contacts and locations

1

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Central trial contact

Lennie Wong, PhD; Lee W Jones, PhD

Data sourced from clinicaltrials.gov

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