Strong People Strength Training Study
Primary Purpose
Heart Diseases, Cardiovascular Diseases, Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strong People Strength Training
Sponsored by

About this trial
This is an interventional prevention trial for Heart Diseases
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
Sites / Locations
- Teton County
- Chouteau County
- Valley County
- Big Horn County
- Hill County
- Wibaux County
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Group 1
Group 2
Arm Description
Group 1 participants attend twice weekly progressive strength training classes with CPR certified and Strong People trained educators in fall 2019 for 12 weeks. Intervention Group.
Group 2 participants receive twice weekly progressive strength training classes in January 2020 for 12 weeks. Delayed Intervention Group.
Outcomes
Primary Outcome Measures
Change from Baseline Hemoglobin A1c at 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
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
body weight
Change from Baseline in American Heart Association's Life's Simple 7 score at 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 Outcome Measures
Change from Baseline Cholesterol at 12 Weeks
Total cholesterol measured with the Alere Cholestech LDX Analyzer
Change from Baseline Resting Heart Rate at 12 Weeks
Heart rate (beats per minute) while at rest
Change from Baseline Blood Pressure at 12 Weeks
Blood pressure measured at rest; systolic over diastolic (mm Hg)
Change from Baseline Functional Fitness Tests at 12 Weeks
Six domains of the functional fitness/ senior fitness tests
Change from Baseline Physical Activity at 12 Weeks measured using accelerometry
Objective physical activity measured using an accelerometer worn for 7 days
Change from Baseline Physical Activity at 12 Weeks measured using self-report
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.
Change from Baseline Fatigue at 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.
Change from Baseline Depression using the Center for Epidemiologic Studies Depression Scale (CES-D) at 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.
Change from Baseline Depression using the Patient Health Questionnaire (PHQ-8) at 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.
Change from Baseline Anxiety at 12 Weeks using the Beck Anxiety Inventory
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.
Change from Baseline Anxiety at 12 Weeks using the the General Anxiety Disorder Scale (GAD-7)
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.
Change from Baseline Stress at 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.
Full Information
NCT ID
NCT04203563
First Posted
October 10, 2019
Last Updated
July 20, 2020
Sponsor
Cornell University
Collaborators
Montana State University, Texas A&M University
1. Study Identification
Unique Protocol Identification Number
NCT04203563
Brief Title
Strong People Strength Training Study
Official Title
Strong People Strength Training Program: A Community-Based Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 20, 2019 (Actual)
Primary Completion Date
December 23, 2019 (Actual)
Study Completion Date
December 23, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornell University
Collaborators
Montana State University, Texas A&M University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases, Cardiovascular Diseases, Diabetes, Sedentary Lifestyle, Overweight and Obesity, Depression, Anxiety, Stress, Fatigue
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1 participants attend twice weekly progressive strength training classes with CPR certified and Strong People trained educators in fall 2019 for 12 weeks.
Group 2 participants receive twice weekly progressive strength training classes in January 2020 for 12 weeks. During the first 12 weeks of the study Group 2 participants do not receive these classes. (Delayed)
Masking
None (Open Label)
Masking Description
Randomization to arm follows the baseline assessment visit.
Allocation
Randomized
Enrollment
167 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Group 1 participants attend twice weekly progressive strength training classes with CPR certified and Strong People trained educators in fall 2019 for 12 weeks. Intervention Group.
Arm Title
Group 2
Arm Type
Other
Arm Description
Group 2 participants receive twice weekly progressive strength training classes in January 2020 for 12 weeks. Delayed Intervention Group.
Intervention Type
Behavioral
Intervention Name(s)
Strong People Strength Training
Intervention Description
A community-based progressive strength training program
Primary Outcome Measure Information:
Title
Change from Baseline Hemoglobin A1c at 12 Weeks
Description
The hemoglobin A1c test tells you your average level of blood sugar over the past 2 to 3 months. It's also called HbA1c.
Time Frame
Baseline and outcome (after 12 weeks)
Title
Change from Baseline BMI at 12 Weeks
Description
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.
Time Frame
Baseline and outcome (after 12 weeks)
Title
Change from Baseline Weight at 12 Weeks
Description
body weight
Time Frame
Baseline and outcome (after 12 weeks)
Title
Change from Baseline in American Heart Association's Life's Simple 7 score at 12 Weeks
Description
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.
Time Frame
Baseline and outcome (after 12 weeks)
Secondary Outcome Measure Information:
Title
Change from Baseline Cholesterol at 12 Weeks
Description
Total cholesterol measured with the Alere Cholestech LDX Analyzer
Time Frame
Baseline and outcome (after 12 weeks)
Title
Change from Baseline Resting Heart Rate at 12 Weeks
Description
Heart rate (beats per minute) while at rest
Time Frame
Baseline and outcome (after 12 weeks)
Title
Change from Baseline Blood Pressure at 12 Weeks
Description
Blood pressure measured at rest; systolic over diastolic (mm Hg)
Time Frame
Baseline and outcome (after 12 weeks)
Title
Change from Baseline Functional Fitness Tests at 12 Weeks
Description
Six domains of the functional fitness/ senior fitness tests
Time Frame
Baseline and outcome (after 12 weeks)
Title
Change from Baseline Physical Activity at 12 Weeks measured using accelerometry
Description
Objective physical activity measured using an accelerometer worn for 7 days
Time Frame
Baseline and outcome (after 12 weeks)
Title
Change from Baseline Physical Activity at 12 Weeks measured using self-report
Description
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.
Time Frame
Baseline and outcome (after 12 weeks)
Title
Change from Baseline Fatigue at 12 Weeks
Description
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.
Time Frame
Baseline and outcome (after 12 weeks)
Title
Change from Baseline Depression using the Center for Epidemiologic Studies Depression Scale (CES-D) at 12 Weeks
Description
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.
Time Frame
Baseline and outcome (after 12 weeks)
Title
Change from Baseline Depression using the Patient Health Questionnaire (PHQ-8) at 12 Weeks
Description
Measured with self report using the Patient Health Questionnaire (PHQ-8). Score ranges from 0 to 24 with greater scores reflecting more depression symptoms.
Time Frame
Baseline and outcome (after 12 weeks)
Title
Change from Baseline Anxiety at 12 Weeks using the Beck Anxiety Inventory
Description
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.
Time Frame
Baseline and outcome (after 12 weeks)
Title
Change from Baseline Anxiety at 12 Weeks using the the General Anxiety Disorder Scale (GAD-7)
Description
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.
Time Frame
Baseline and outcome (after 12 weeks)
Title
Change from Baseline Stress at 12 Weeks
Description
Measured with self report using the Perceived Stress Scale (PSS). Scores range from 0 to 40 with higher scores reflecting more perceived stress.
Time Frame
Baseline and outcome (after 12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca A Seguin-Fowler, PhD
Organizational Affiliation
Texas A&M AgriLife Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Teton County
City
Choteau
State/Province
Montana
ZIP/Postal Code
59436
Country
United States
Facility Name
Chouteau County
City
Fort Benton
State/Province
Montana
ZIP/Postal Code
59442
Country
United States
Facility Name
Valley County
City
Glasgow
State/Province
Montana
ZIP/Postal Code
59230
Country
United States
Facility Name
Big Horn County
City
Hardin
State/Province
Montana
ZIP/Postal Code
59034
Country
United States
Facility Name
Hill County
City
Havre
State/Province
Montana
ZIP/Postal Code
59501
Country
United States
Facility Name
Wibaux County
City
Wibaux
State/Province
Montana
ZIP/Postal Code
59353
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Strong People Strength Training Study
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