- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02677363
Functional Outcomes of Stay Strong Stay Healthy Program
April 2, 2018 updated by: University of Missouri-Columbia
Functional Outcomes of Stay Strong, Stay Healthy Program
Strength training can increase muscle mass and strength while improving bone density and reducing risk for osteoporosis and related fractures.
Strength training can also lead to reduced risk for diabetes, heart disease, arthritis, depression, and obesity; and improves self-confidence, sleep and vitality.
Research demonstrates that strength training is extremely effective in helping aging adults with chronic conditions prevent further onset of disease and, in many instances, actually reverse the disease process.
In Stay Strong, Stay Healthy Program elderly subjects perform resistance exercise training (RET) twice every week.
Past literature suggests that resistance training improved muscle activity, muscle strength, muscle mass, and bone mineral density and total body composition, and adiponectin, insulin sensitivity, fasting blood-glucose (BG), HbA1c1 (long-term marker of BG), blood pressure (BP), blood triglycerides (TGs) and low density lipoproteins (LDL) in healthy and diabetic subjects.
The purpose of this study is to measure the changes in the above discussed variables after 8-weeks of resistance exercises.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants will perform resistance exercise for 8 weeks and measurements (anthropometric, electromyography, pulse wave velocity, strength test, dual x-ray absorptiometry, blood enzymes/hormones, and sleep, diet, memory surveys) will be performed pre- and post-exercise program.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
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Columbia, Missouri, United States, 65211
- University of Missouri-Columbia
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 60 or above
- Enrollment in Stay Strong Stay Healthy Program
- Strength training < 2 hours/week for past 3 months
Exclusion Criteria:
- Not enrolled in Stay Strong Stay Healthy Program
- Strength training > 2 hours/week for past 3 months
- Donated more than 463 ml of blood in past 8 weeks
- Physician discouraged to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Older adults
Participants 60 and above aged (both females and males) will perform one hour of resistance exercise twice weekly for 8 weeks.
|
Participants 60 and above aged (both females and males) will perform one hour of resistance exercise twice weekly for 8 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle electrical activity
Time Frame: Change in muscle electrical activity in 8 weeks in response to resistance exercise program
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Measurement of muscle electrical activity is made using electromyography technique at baseline and after 8 weeks of resistance exercise.
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Change in muscle electrical activity in 8 weeks in response to resistance exercise program
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exert muscle power/strength
Time Frame: Change in muscle power/strength in 8 weeks in response to resistance exercise program
|
Measurement of muscle power/strength is made using hand dynamometer at baseline and after 8 weeks of resistance exercise.
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Change in muscle power/strength in 8 weeks in response to resistance exercise program
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Muscle mass loss
Time Frame: Change in muscle mass in 8 weeks in response to resistance exercise program
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Changes in the muscle mass is made using dual x-ray absorptiometry technique at baseline and after 8 weeks of resistance exercise.
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Change in muscle mass in 8 weeks in response to resistance exercise program
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Ability to think or remember
Time Frame: Changes in thinking and cognitive abilities in 8 weeks in response to resistance exercise program
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Changes in ability to think or remember is measured by using standard survey (Self Administered Gerocognitive Exam Form -1) at baseline and after 8 weeks of resistance exercise.
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Changes in thinking and cognitive abilities in 8 weeks in response to resistance exercise program
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephen D Ball, PhD, University of Missouri-Columbia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Geirsdottir OG, Arnarson A, Briem K, Ramel A, Jonsson PV, Thorsdottir I. Effect of 12-week resistance exercise program on body composition, muscle strength, physical function, and glucose metabolism in healthy, insulin-resistant, and diabetic elderly Icelanders. J Gerontol A Biol Sci Med Sci. 2012 Nov;67(11):1259-65. doi: 10.1093/gerona/gls096. Epub 2012 Apr 10.
- Sale DG. Neural adaptation to resistance training. Med Sci Sports Exerc. 1988 Oct;20(5 Suppl):S135-45. doi: 10.1249/00005768-198810001-00009.
- Pollock ML, Franklin BA, Balady GJ, Chaitman BL, Fleg JL, Fletcher B, Limacher M, Pina IL, Stein RA, Williams M, Bazzarre T. AHA Science Advisory. Resistance exercise in individuals with and without cardiovascular disease: benefits, rationale, safety, and prescription: An advisory from the Committee on Exercise, Rehabilitation, and Prevention, Council on Clinical Cardiology, American Heart Association; Position paper endorsed by the American College of Sports Medicine. Circulation. 2000 Feb 22;101(7):828-33. doi: 10.1161/01.cir.101.7.828. No abstract available.
- Mayer F, Scharhag-Rosenberger F, Carlsohn A, Cassel M, Muller S, Scharhag J. The intensity and effects of strength training in the elderly. Dtsch Arztebl Int. 2011 May;108(21):359-64. doi: 10.3238/arztebl.2011.0359. Epub 2011 May 27.
- Kraemer WJ, Ratamess NA. Hormonal responses and adaptations to resistance exercise and training. Sports Med. 2005;35(4):339-61. doi: 10.2165/00007256-200535040-00004.
- Macaluso A, De Vito G. Muscle strength, power and adaptations to resistance training in older people. Eur J Appl Physiol. 2004 Apr;91(4):450-72. doi: 10.1007/s00421-003-0991-3. Epub 2003 Nov 25.
- Ball S, Gammon R, Kelly PJ, Cheng AL, Chertoff K, Kaume L, Abreu EL, Brotto M. Outcomes of Stay Strong, Stay Healthy in community settings. J Aging Health. 2013 Dec;25(8):1388-97. doi: 10.1177/0898264313507318. Epub 2013 Oct 22.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
February 2, 2016
First Submitted That Met QC Criteria
February 3, 2016
First Posted (Estimate)
February 9, 2016
Study Record Updates
Last Update Posted (Actual)
April 3, 2018
Last Update Submitted That Met QC Criteria
April 2, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 208531
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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