Clinical trial NCT04203563: Strong People Strength Training Study
Official title: Strong People Strength Training Program: A Community-Based Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Cardiovascular Diseases
Diabetes
Sedentary Lifestyle
Overweight and Obesity
Depression, Anxiety
Stress
Fatigue
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: Montana State University
name: Texas A&M University
First posted: 2019-12-18
Enrollment: 167
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change from Baseline Hemoglobin A1c at 12 Weeks
timeFrame: Baseline and outcome (after 12 weeks)
measure: Change from Baseline BMI at 12 Weeks
timeFrame: Baseline and outcome (after 12 weeks)
measure: Change from Baseline Weight at 12 Weeks
timeFrame: Baseline and outcome (after 12 weeks)
measure: Change from Baseline in American Heart Association's Life's Simple 7 score at 12 Weeks
timeFrame: Baseline and outcome (after 12 weeks)
Secondary outcomes:
measure: Change from Baseline Cholesterol at 12 Weeks
timeFrame: Baseline and outcome (after 12 weeks)
measure: Change from Baseline Resting Heart Rate at 12 Weeks
timeFrame: Baseline and outcome (after 12 weeks)
measure: Change from Baseline Blood Pressure at 12 Weeks
timeFrame: Baseline and outcome (after 12 weeks)
measure: Change from Baseline Functional Fitness Tests at 12 Weeks
timeFrame: Baseline and outcome (after 12 weeks)
measure: Change from Baseline Physical Activity at 12 Weeks measured using accelerometry
timeFrame: Baseline and outcome (after 12 weeks)
measure: Change from Baseline Physical Activity at 12 Weeks measured using self-report
timeFrame: Baseline and outcome (after 12 weeks)
measure: Change from Baseline Fatigue at 12 Weeks
timeFrame: Baseline and outcome (after 12 weeks)
measure: Change from Baseline Depression using the Center for Epidemiologic Studies Depression Scale (CES-D) at 12 Weeks
timeFrame: Baseline and outcome (after 12 weeks)
measure: Change from Baseline Depression using the Patient Health Questionnaire (PHQ-8) at 12 Weeks
timeFrame: Baseline and outcome (after 12 weeks)
measure: Change from Baseline Anxiety at 12 Weeks using the Beck Anxiety Inventory
timeFrame: Baseline and outcome (after 12 weeks)
measure: Change from Baseline Anxiety at 12 Weeks using the the General Anxiety Disorder Scale (GAD-7)
timeFrame: Baseline and outcome (after 12 weeks)
measure: Change from Baseline Stress at 12 Weeks
timeFrame: Baseline and outcome (after 12 weeks)
Other outcomes:
Locations:
city: Choteau
country: United States
facility: Teton County
state: Montana
city: Fort Benton
country: United States
facility: Chouteau County
state: Montana
city: Glasgow
country: United States
facility: Valley County
state: Montana
city: Hardin
country: United States
facility: Big Horn County
state: Montana
city: Havre
country: United States
facility: Hill County
state: Montana
city: Wibaux
country: United States
facility: Wibaux County
state: Montana
Study officials:
affiliation: Texas A&M AgriLife Research
name: Rebecca A Seguin-Fowler, PhD
role: PRINCIPAL_INVESTIGATOR
References: