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NCT Number: NCT07224659

Exercise and Mortality in Middle-Aged and Older Adults

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).

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Key information

Conditions

Overall Survival (All-cause Mortality)

Age range

55 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Control

Behavioral

0 or less than 1 day per week, with each session, on average < 15 minutes.

Exercise

Behavioral

>/= 2 days per week of moderate or vigorous intensity, with each session, on average, >/=20 minutes in duration.

Primary outcomes

  1. Overall survival (all-cause mortality)

    Time frame: up to 19 years

    All-cause mortality (death from any cause) occurring within the follow-up period in the PLCO screening trial.

  2. Cause-specific mortality

    Time frame: up to 19 years

    Cause-specific mortality (cancer mortality, mortality from other causes) occurring within the total follow-up period in the PLCO screening trial.

Secondary outcomes

  1. Cancer incidence

    Time frame: up to 19 years

    Cancer incidence occurring within the total follow-up period in the PLCO screening trial.

Other outcomes

  1. Exploratory Analyses #1

    Time frame: up to 19 years

    Analyses to examine whether the association between exercise vs. control with all-cause mortality differs as a function of:

    • Sex (male vs. female)
    • Age (<50 years vs. =/>50 years)

  2. Exploratory Analyses #2

    Time frame: up to 19 years

    Examine the association between exercise vs. control with incidence of individual cancer types.

Study contacts

Contact information is provided by the study sponsor or research team.

Lee W Jones, PhD

CONTACT

[email protected]

626-218-3844

Lennie Wong, PhD

CONTACT

[email protected]

626-218-3844

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 5, 2025
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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