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Completed

NCT Number: NCT04203563

Strong People Strength Training Study

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.

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Key information

Conditions

Heart Diseases Anxiety Disorders Behavior Behavioral Symptoms Body Weight Cardiovascular Diseases Depression Depression, Anxiety Diabetes Diabetes Mellitus Endocrine System Diseases Fatigue Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Sedentary Behavior Sedentary Lifestyle Signs and Symptoms Stress

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Teton County, Choteau, Montana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Strong People Strength Training

Behavioral

A community-based progressive strength training program

Primary outcomes

  1. 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.

  2. 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.

  3. Change from Baseline Weight at 12 Weeks

    Time frame: Baseline and outcome (after 12 weeks)

    body weight

  4. 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

  1. Change from Baseline Cholesterol at 12 Weeks

    Time frame: Baseline and outcome (after 12 weeks)

    Total cholesterol measured with the Alere Cholestech LDX Analyzer

  2. Change from Baseline Resting Heart Rate at 12 Weeks

    Time frame: Baseline and outcome (after 12 weeks)

    Heart rate (beats per minute) while at rest

  3. Change from Baseline Blood Pressure at 12 Weeks

    Time frame: Baseline and outcome (after 12 weeks)

    Blood pressure measured at rest; systolic over diastolic (mm Hg)

  4. Change from Baseline Functional Fitness Tests at 12 Weeks

    Time frame: Baseline and outcome (after 12 weeks)

    Six domains of the functional fitness/ senior fitness tests

  5. Change from Baseline Physical Activity at 12 Weeks measured using accelerometry

    Time frame: Baseline and outcome (after 12 weeks)

    Objective physical activity measured using an accelerometer worn for 7 days

  6. Change from Baseline Physical Activity at 12 Weeks measured using self-report

    Time frame: Baseline and outcome (after 12 weeks)

    Self-report physical activity measured using CHAMPS Activities Questionnaire for Older Adults.

    Questionnaire includes 41 activity questions and participant reports on number of hours per week involved in each activity using possible responses: less than 1 hour; 1-2.5 hours; 3-4.5 hours; 5-6.5 hours; 7-8.5 hours; 9 or more hours. More hours reported corresponds with more time in physical activity.

  7. Change from Baseline Fatigue at 12 Weeks

    Time frame: Baseline and outcome (after 12 weeks)

    Measured with self report using the Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F). This validated scale consists of 18 items relating to the experience of fatigue. Each item the participant responds on a scale of 0 to 10. For example with 0 being not at all tired and 10 being extremely tired.

  8. Change from Baseline Depression using the Center for Epidemiologic Studies Depression Scale (CES-D) at 12 Weeks

    Time frame: Baseline and outcome (after 12 weeks)

    Measured with self report using the Center for Epidemiologic Studies Depression Scale (CES-D). Score ranges from 0 to 60 with with higher scores indicating the presence of more depression symptoms.

  9. Change from Baseline Depression using the Patient Health Questionnaire (PHQ-8) at 12 Weeks

    Time frame: Baseline and outcome (after 12 weeks)

    Measured with self report using the Patient Health Questionnaire (PHQ-8). Score ranges from 0 to 24 with greater scores reflecting more depression symptoms.

  10. Change from Baseline Anxiety at 12 Weeks using the Beck Anxiety Inventory

    Time frame: Baseline and outcome (after 12 weeks)

    Anxiety measured by questionnaire using the Beck Anxiety Inventory which is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety. Scores range from 0 to 63 with higher scores indicating more anxiety.

  11. Change from Baseline Anxiety at 12 Weeks using the the General Anxiety Disorder Scale (GAD-7)

    Time frame: Baseline and outcome (after 12 weeks)

    Anxiety measured by questionnaire using the General Anxiety Disorder Scale (GAD-7) which consists of 7 questions with responses from Not at all, Several Days, More than half hte days, and Nearly every day. Scores range from 0 to 21 with higher scores reflecting more anxiety.

  12. Change from Baseline Stress at 12 Weeks

    Time frame: Baseline and outcome (after 12 weeks)

    Measured with self report using the Perceived Stress Scale (PSS). Scores range from 0 to 40 with higher scores reflecting more perceived stress.

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Collaborators

  • Montana State University
  • Texas A&M University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 18, 2019
Registry last updated
Jul 21, 2020

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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