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Not yet recruiting NCT07224659

Exercise and Mortality in Middle-Aged and Older Adults

Observational Overall Survival (All-cause Mortality)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Control, Exercise.
Who it may be relevant to
Registry conditions: Overall Survival (All-cause Mortality). Basic parameters: 55 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Exercise and Mortality in Middle-Aged and Older Adults: A Target Trial Emulation

Overview

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).

Interventions

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

Primary outcome measures

  • Overall survival (all-cause mortality) [Time frame: up to 19 years]
  • Cause-specific mortality [Time frame: up to 19 years]
Secondary outcome measures (1)
  • Cancer incidence [Time frame: up to 19 years]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • City of Hope Medical Center — Duarte

Identifiers

NCT: NCT07224659 · 25603

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗