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Clinical Trials/NCT04203563
NCT04203563
Completed
N/A

Strong People Strength Training Program: A Community-Based Randomized Trial

Cornell University6 sites in 1 country167 target enrollmentAugust 20, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Diseases
Sponsor
Cornell University
Enrollment
167
Locations
6
Primary Endpoint
Change from Baseline Hemoglobin A1c at 12 Weeks
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The Strong People Strength Training study aims to assess whether a community-based progressive strength training program can improve risk factors for diabetes and heart disease in older rural adults.

Detailed Description

This study aims to evaluate the effects of a twice weekly, 12-week progressive strength training program, Strong People Strength Training, on cardiometabolic risk factors in a pragmatic, community-based randomized intervention trial among rural men and women 50 and older. We hypothesize that individuals randomized to the intervention group will demonstrate statistically significant and clinically meaningful improvements in cardiometabolic risk factors as well as physical function, quality of life, and physical activity compared to those randomized to the delayed intervention control group.

Registry
clinicaltrials.gov
Start Date
August 20, 2019
End Date
December 23, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 50 or older
  • Willing and able to get health care provider (HCP) authorization if required (PAR-Q answered yes to any question or 70 and older)

Exclusion Criteria

  • Strength trained in last 12 months
  • Previous enrollment in Strong People
  • Enrolled or planning to enroll in lifestyle program
  • Cognitive impairment
  • Unable to obtain physician authorization

Outcomes

Primary Outcomes

Change from Baseline Hemoglobin A1c at 12 Weeks

Time Frame: Baseline and outcome (after 12 weeks)

The hemoglobin A1c test tells you your average level of blood sugar over the past 2 to 3 months. It's also called HbA1c.

Change from Baseline BMI at 12 Weeks

Time Frame: Baseline and outcome (after 12 weeks)

Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.

Change from Baseline Weight at 12 Weeks

Time Frame: Baseline and outcome (after 12 weeks)

body weight

Change from Baseline in American Heart Association's Life's Simple 7 score at 12 Weeks

Time Frame: Baseline and outcome (after 12 weeks)

The American Heart Association's Life's Simple 7 score is comprised of seven cardiovascular disease (CVD) risk factors: physical activity, healthy diet score, blood glucose, BMI, blood cholesterol, blood pressure, and smoking; each risk factor is categorized as ideal, intermediate, or poor. Minimum value is 0, Maximum value is 14. Higher scores on the scale represent a better outcome.

Secondary Outcomes

  • Change from Baseline Fatigue at 12 Weeks(Baseline and outcome (after 12 weeks))
  • Change from Baseline Depression using the Patient Health Questionnaire (PHQ-8) at 12 Weeks(Baseline and outcome (after 12 weeks))
  • Change from Baseline Anxiety at 12 Weeks using the Beck Anxiety Inventory(Baseline and outcome (after 12 weeks))
  • Change from Baseline Cholesterol at 12 Weeks(Baseline and outcome (after 12 weeks))
  • Change from Baseline Resting Heart Rate at 12 Weeks(Baseline and outcome (after 12 weeks))
  • Change from Baseline Blood Pressure at 12 Weeks(Baseline and outcome (after 12 weeks))
  • Change from Baseline Functional Fitness Tests at 12 Weeks(Baseline and outcome (after 12 weeks))
  • Change from Baseline Physical Activity at 12 Weeks measured using accelerometry(Baseline and outcome (after 12 weeks))
  • Change from Baseline Physical Activity at 12 Weeks measured using self-report(Baseline and outcome (after 12 weeks))
  • Change from Baseline Depression using the Center for Epidemiologic Studies Depression Scale (CES-D) at 12 Weeks(Baseline and outcome (after 12 weeks))
  • Change from Baseline Anxiety at 12 Weeks using the the General Anxiety Disorder Scale (GAD-7)(Baseline and outcome (after 12 weeks))
  • Change from Baseline Stress at 12 Weeks(Baseline and outcome (after 12 weeks))

Study Sites (6)

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