Exercise and Mortality in Middle-Aged and Older Adults

ConditionOverall Survival (All-cause Mortality)

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age55-74

SponsorCity of Hope Medical Center

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

Adults enrolled into the PLCO screening trial

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

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.

Treatment groups

19,000 Participants

are divided into 2 treatment groups

Group A: Arm 1 - Control1 intervention

Group B: Arm 2 - Exercise1 intervention

Trial outcomes

Primary outcomes

Overall survival (all-cause mortality)

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

Time frame

up to 19 years

Cause-specific mortality

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

Time frame

up to 19 years

Secondary outcomes

Cancer incidence

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

Time frame

up to 19 years

Other outcomes

Exploratory Analyses #1

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)

Time frame

up to 19 years

Exploratory Analyses #2

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

Time frame

up to 19 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: