Strong People Strength Training Study

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04203563
• Other study ID #: MG071019
• Status: Completed
• Phase: N/A
• Start date: August 20, 2019
• Est. completion date: December 23, 2019

Study information

• Verified date: July 2020
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: December 23, 2019
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Depression, Anxiety
• Diabetes
• Fatigue
• Heart Diseases
• Overweight
• Overweight and Obesity
• Sedentary Lifestyle
• Stress

Intervention

Behavioral:
• Strong People Strength Training
A community-based progressive strength training program

Locations

Country	Name	City	State
United States	Teton County	Choteau	Montana
United States	Chouteau County	Fort Benton	Montana
United States	Valley County	Glasgow	Montana
United States	Big Horn County	Hardin	Montana
United States	Hill County	Havre	Montana
United States	Wibaux County	Wibaux	Montana

Sponsors (3)

Lead Sponsor	Collaborator
Cornell University	Montana State University, Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and outcome (after 12 weeks)
Primary	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.	Baseline and outcome (after 12 weeks)
Primary	Change from Baseline Weight at 12 Weeks	body weight	Baseline and outcome (after 12 weeks)
Primary	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.	Baseline and outcome (after 12 weeks)
Secondary	Change from Baseline Cholesterol at 12 Weeks	Total cholesterol measured with the Alere Cholestech LDX Analyzer	Baseline and outcome (after 12 weeks)
Secondary	Change from Baseline Resting Heart Rate at 12 Weeks	Heart rate (beats per minute) while at rest	Baseline and outcome (after 12 weeks)
Secondary	Change from Baseline Blood Pressure at 12 Weeks	Blood pressure measured at rest; systolic over diastolic (mm Hg)	Baseline and outcome (after 12 weeks)
Secondary	Change from Baseline Functional Fitness Tests at 12 Weeks	Six domains of the functional fitness/ senior fitness tests	Baseline and outcome (after 12 weeks)
Secondary	Change from Baseline Physical Activity at 12 Weeks measured using accelerometry	Objective physical activity measured using an accelerometer worn for 7 days	Baseline and outcome (after 12 weeks)
Secondary	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.	Baseline and outcome (after 12 weeks)
Secondary	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.	Baseline and outcome (after 12 weeks)
Secondary	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.	Baseline and outcome (after 12 weeks)
Secondary	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.	Baseline and outcome (after 12 weeks)
Secondary	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.	Baseline and outcome (after 12 weeks)
Secondary	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.	Baseline and outcome (after 12 weeks)
Secondary	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.	Baseline and outcome (after 12 weeks)