Quality of LifeNCT02677363
Functional Outcomes of Stay Strong Stay Healthy Program
A study testing Resistance Exercise in people with Quality of Life and Aging, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Aging, Memory Loss
- What is being tested?
- Resistance Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Jun 2017
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60 or above
- Enrollment in Stay Strong Stay Healthy Program
- Strength training < 2 hours/week for past 3 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Columbia
Columbia, Missouri, 65211
About this study
Official title: 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.
Read the 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.
- Conditions
- Quality of Life, Aging, Memory Loss, Cardiovascular Diseases
- Being tested
- Resistance Exercise
- Keywords
- Elderly, Older, Adults, Resistant Exercise, Strength Training, Cognitive function
- Medical subject headings
- Memory Disorders, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseOther
Also called Strength training
Participants 60 and above aged (both females and males) will perform one hour of resistance exercise twice weekly for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Older adults | Experimental | Participants 60 and above aged (both females and males) will perform one hour of resistance exercise twice weekly for 8 weeks. Receives: Other: Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle electrical activity
Measurement of muscle electrical activity is made using electromyography technique at baseline and after 8 weeks of resistance exercise.
Measured: Change in muscle electrical activity in 8 weeks in response to resistance exercise program
Secondary outcomes (3)
Exert muscle power/strength
Measurement of muscle power/strength is made using hand dynamometer at baseline and after 8 weeks of resistance exercise.
Measured: Change in muscle power/strength in 8 weeks in response to resistance exercise program
Muscle mass loss
Changes in the muscle mass is made using dual x-ray absorptiometry technique at baseline and after 8 weeks of resistance exercise.
Measured: Change in muscle mass in 8 weeks in response to resistance exercise program
Ability to think or remember
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.
Measured: Changes in thinking and cognitive abilities in 8 weeks in response to resistance exercise program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen D Ball, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677363
- Sponsor's protocol ID
- 208531
- Status last verified
- Apr 2018
- First submitted
- 2 Feb 2016
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 22496538Sale DG. Neural adaptation to resistance training. Med Sci Sports Exerc. 1988 Oct;20(5 Suppl):S135-45. doi: 10.1249/00005768-198810001-00009.
PubMed 3057313Pollock 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.
PubMed 10683360Mayer 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.
PubMed 21691559Kraemer 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.
PubMed 15831061Macaluso 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.
PubMed 14639481Ball 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.
PubMed 24150062
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes of Stay Strong, Stay Healthy Program
- ClinicalTrials.gov ID
- NCT02677363
- Acronym / sponsor ID
- 208531
- Conditions
- Quality of Life, Aging, Memory Loss, Cardiovascular Diseases
- Keywords
- Elderly, Older, Adults, Resistant Exercise, Strength Training, Cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 9 Feb 2016 (estimated)
- 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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults | Experimental | Other: Resistance ExerciseParticipants 60 and above aged (both females and males) will perform one hour of resistance exercise twice weekly for 8 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 60 or above
- Enrollment in Stay Strong Stay Healthy Program
- Strength training < 2 hours/week for past 3 months
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Resistance ExerciseAlso: Strength trainingParticipants 60 and above aged (both females and males) will perform one hour of resistance exercise twice weekly for 8 weeks. | Other | Older adults |
Primary outcome
Muscle electrical activity
Time frame: Change in muscle electrical activity in 8 weeks in response to resistance exercise program
Measurement of muscle electrical activity is made using electromyography technique at baseline and after 8 weeks of resistance exercise.
3 secondary outcomes
Exert muscle power/strength
Time frame: Change in muscle power/strength in 8 weeks in response to resistance exercise program
Muscle mass loss
Time frame: Change in muscle mass in 8 weeks in response to resistance exercise program
Ability to think or remember
Time frame: Changes in thinking and cognitive abilities in 8 weeks in response to resistance exercise program
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 3 Apr 2018.
- Background: PubMed 22496538Geirsdottir 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.
- Background: PubMed 3057313Sale DG. Neural adaptation to resistance training. Med Sci Sports Exerc. 1988 Oct;20(5 Suppl):S135-45. doi: 10.1249/00005768-198810001-00009.
- Background: PubMed 10683360Pollock 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.
- Background: PubMed 21691559Mayer 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.
- Background: PubMed 15831061Kraemer 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.
- Background: PubMed 14639481Macaluso 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.
- Results publication: PubMed 24150062Ball 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.
- Individual participant dataSharing planned: No
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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.
Stephen D Ball, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise in people with Quality of Life and Aging, run by University of Missouri-Columbia at 1 site 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 3 inclusion and 4 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 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Muscle electrical activity (time frame: Change in muscle electrical activity in 8 weeks in response to resistance exercise program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02677363, which also lists 7 linked publications.
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 3 Apr 2018.