Exercise and Mortality in Middle-Aged and Older Adults

NCT ID: NCT07224659

Last Updated: 2025-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

19000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-08-06

Brief Summary

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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).

Detailed Description

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Conditions

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Overall Survival (All-cause Mortality)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Arm 1 - Control

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

Control

Intervention Type BEHAVIORAL

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

Arm 2 - Exercise

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

Exercise

Intervention Type BEHAVIORAL

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

Interventions

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Control

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

Intervention Type BEHAVIORAL

Exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status

Countries

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United States

Central Contacts

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Lee W Jones, PhD

Role: CONTACT

626-218-3844

Lennie Wong, PhD

Role: CONTACT

626-218-3844

Other Identifiers

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25603

Identifier Type: -

Identifier Source: org_study_id

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