Heart DiseasesNCT04203563
Strong People Strength Training Study
A study testing Strong People Strength Training in people with Heart Diseases and Cardiovascular Diseases, run by Cornell University at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases, Cardiovascular Diseases, Diabetes
- What is being tested?
- Strong People Strength Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 Aug 2019to 23 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Teton County
Choteau, Montana, 59436
Chouteau County
Fort Benton, Montana, 59442
Valley County
Glasgow, Montana, 59230
Big Horn County
Hardin, Montana, 59034
Hill County
Havre, Montana, 59501
Wibaux County
Wibaux, Montana, 59353
About this study
Official title: Strong People Strength Training Program: A Community-Based Randomized Trial
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.
Read the 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.
- Conditions
- Heart Diseases, Cardiovascular Diseases, Diabetes, Sedentary Lifestyle, Overweight and Obesity, Depression, Anxiety
- Being tested
- Strong People Strength Training
- Medical subject headings
- Heart Diseases, Cardiovascular Diseases, Diabetes Mellitus, Sedentary Behavior, Overweight, Obesity, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strong People Strength TrainingBehavioural
A community-based progressive strength training program
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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. Receives: Behavioral: Strong People Strength Training |
| Group 2 | Other | Group 2 participants receive twice weekly progressive strength training classes in January 2020 for 12 weeks. Delayed Intervention Group. Receives: Behavioral: Strong People Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and outcome (after 12 weeks)
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.
Measured: Baseline and outcome (after 12 weeks)
Change from Baseline Weight at 12 Weeks
body weight
Measured: Baseline and outcome (after 12 weeks)
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.
Measured: Baseline and outcome (after 12 weeks)
Secondary outcomes (12)
Change from Baseline Cholesterol at 12 Weeks
Total cholesterol measured with the Alere Cholestech LDX Analyzer
Measured: Baseline and outcome (after 12 weeks)
Change from Baseline Resting Heart Rate at 12 Weeks
Heart rate (beats per minute) while at rest
Measured: Baseline and outcome (after 12 weeks)
Change from Baseline Blood Pressure at 12 Weeks
Blood pressure measured at rest; systolic over diastolic (mm Hg)
Measured: Baseline and outcome (after 12 weeks)
Change from Baseline Functional Fitness Tests at 12 Weeks
Six domains of the functional fitness/ senior fitness tests
Measured: Baseline and outcome (after 12 weeks)
Change from Baseline Physical Activity at 12 Weeks measured using accelerometry
Objective physical activity measured using an accelerometer worn for 7 days
Measured: Baseline and outcome (after 12 weeks)
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.
Measured: Baseline and outcome (after 12 weeks)
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.
Measured: Baseline and outcome (after 12 weeks)
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.
Measured: Baseline and outcome (after 12 weeks)
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.
Measured: Baseline and outcome (after 12 weeks)
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.
Measured: Baseline and outcome (after 12 weeks)
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.
Measured: Baseline and outcome (after 12 weeks)
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.
Measured: Baseline and outcome (after 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start20 Aug 2019
- Primary completion23 Dec 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Montana State University, Texas A&M University
- Responsible party
- Sponsor
- Investigators
- Rebecca A Seguin-Fowler, PhD, Principal investigator, Texas A&M AgriLife Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203563
- Sponsor's protocol ID
- MG071019
- Status last verified
- Jul 2020
- First submitted
- 10 Oct 2019
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strong People Strength Training Program: A Community-Based Randomized Trial
- ClinicalTrials.gov ID
- NCT04203563
- Acronym / sponsor ID
- MG071019
- Conditions
- Heart Diseases, Cardiovascular Diseases, Diabetes, Sedentary Lifestyle, Overweight and Obesity, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- Montana State University, Texas A&M University
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Strong People Strength TrainingGroup 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 | Other | Behavioral: Strong People Strength TrainingGroup 2 participants receive twice weekly progressive strength training classes in January 2020 for 12 weeks. Delayed Intervention Group. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strong People Strength TrainingA community-based progressive strength training program | Behavioural | Group 1, Group 2 |
Primary outcome
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.
12 secondary outcomes
Change from Baseline Cholesterol at 12 Weeks
Time frame: Baseline and outcome (after 12 weeks)
Change from Baseline Resting Heart Rate at 12 Weeks
Time frame: Baseline and outcome (after 12 weeks)
Change from Baseline Blood Pressure at 12 Weeks
Time frame: Baseline and outcome (after 12 weeks)
Change from Baseline Functional Fitness Tests at 12 Weeks
Time frame: Baseline and outcome (after 12 weeks)
Change from Baseline Physical Activity at 12 Weeks measured using accelerometry
Time frame: Baseline and outcome (after 12 weeks)
Change from Baseline Physical Activity at 12 Weeks measured using self-report
Time frame: Baseline and outcome (after 12 weeks)
Change from Baseline Fatigue at 12 Weeks
Time frame: Baseline and outcome (after 12 weeks)
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)
Change from Baseline Depression using the Patient Health Questionnaire (PHQ-8) at 12 Weeks
Time frame: Baseline and outcome (after 12 weeks)
Change from Baseline Anxiety at 12 Weeks using the Beck Anxiety Inventory
Time frame: Baseline and outcome (after 12 weeks)
Change from Baseline Anxiety at 12 Weeks using the the General Anxiety Disorder Scale (GAD-7)
Time frame: Baseline and outcome (after 12 weeks)
Change from Baseline Stress at 12 Weeks
Time frame: Baseline and outcome (after 12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca A Seguin-Fowler, PhD principal investigator
Texas A&M AgriLife Research
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strong People Strength Training in people with Heart Diseases and Cardiovascular Diseases, run by Cornell University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Hemoglobin A1c at 12 Weeks (time frame: Baseline and outcome (after 12 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.