Study Results
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
52 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-05-23
Study Completion Date
2019-12-31
Brief Summary
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The University of Missouri's Stay Strong, Stay Healthy (SSSH) program is an eight week strength training class for older adults. Exercise training programs, like SSSH, can increase muscle mass and strength, improve bone density and reduce the risk of osteoporosis and related fractures, improve diabetes, heart disease, arthritis, depression, and obesity; and increase self-confidence, sleep and vitality in older adults. Specifically, the SSSH program has been shown to increase elderly individuals' confidence in their physical abilities. The primary objective of this research study is to track physiologic changes and determine the effectiveness of the SSSH exercise intervention to improve balance and fall risk in older adults. Participant's balance, gait, muscle strength, body composition, and skeletal health will be compared to a walking group and to a sedentary control group prior to and immediately following the eight week exercise intervention. After the intervention period participants will have the opportunity to participate in an interview process to further discuss their experiences and perceptions regarding the intervention and their health.
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Detailed Description
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Research Background and Objectives The University of Missouri's Stay Strong, Stay Healthy (SSSH) program is an eight week strength training class for older adults. SSSH is modeled after the evidence-based StrongWomen program developed by researchers at Friedman School of Nutrition Sciences at Tufts University. While the original Tufts program included only women, University of Missouri Extension has adapted the curriculum to also include men. Strength training programs, like SSSH, can increase muscle mass and strength, improve bone density and reduce the risk of osteoporosis and related fractures, improve diabetes, heart disease, arthritis, depression, and obesity; and increase self-confidence, sleep and vitality in older adults. Specifically, the SSSH program increases elderly individuals' confidence in their physical strength and balance. The present study will elucidate the effects of the SSSH program on specific measures of balance, muscle capacity, and skeletal health in a cohort of older adults from Central Missouri.
The primary objective of the quantitative part of the research study is to track physiologic changes and determine the effectiveness of the SSSH exercise intervention in older adults. Participant's balance, gait, muscle strength, body composition, and skeletal health will be compared to a walking group and to a sedentary control group prior to and immediately following the eight week exercise intervention.
Participant centered objectives include:
* Participants will improve their balance, thus reducing their risk for falls.
* Participants will increase their muscle strength and improve body composition.
* Participants will increase their rate of bone formation.
* Participants will improve their cognition and sleep habits.
* Participants will increase their physical activity
The primary objective of the qualitative part of the research study is to explore perceptions of the impact of physical activity and changes in behaviors and attitudes of participants who completed the intervention period. The sequential approach of this study will (1) explore the effects of participating in the Stay Strong, Stay Healthy study that were difficult to measure quantitatively and (2) help interpret the quantitative findings and understanding.
Topics that will guide the qualitative study include participants':
* Concerns, motivations/benefits, and needs/barriers to physical activity
* Perceptions of social influences on physical activity
* Perceptions of impact of physical activity on psychological and emotional well-being, cognition, and sleep
* Perceptions of confidence related to fear of falling
* Perceptions of changes in behaviors and attitudes based on bone density test results
Recruitment Process The Stay Strong, Stay Healthy program is conducted throughout the state of Missouri. Class sessions are advertised by posting flyers and in newspapers. At the University of Missouri-Columbia, the SSSH program is advertised by posting flyers around campus and utilizing the email group for retired MU employees. Dr. Baker and research staff will also present the research study participation opportunity at pre SSSH sessions in Columbia and surrounding areas. The investigators will be available to answer questions via email and phone for any potential participants prior to their first visit on campus. The inclusion and exclusion criteria listed below in addition to the PAR-Q form will make up the initial screening form. During the recruitment process research staff will use this form to quickly screen potential participants for overt exclusion criteria, thus reducing the number of "screen failure" participants who will have to coordinate travel to campus for the first consenting visit. No personal health information is contained in these forms and all questions are yes/no, and this data will only be recorded for screening failures to inform selection bias. The inclusion of this form is purely the research team's attempt to reduce patient burden as travel can be very difficult for this patient population.
Consent Process Only research staff cleared to obtain written consent will escort participants to a private room in Gwynn Hall, where all screening and consenting will take place. After participants have cleared the initial screening checklist (the PAR-Q form and inclusion/exclusion criteria), research staff will deliberately and clearly explain each aspect of the informed consent. Participants will be encouraged to ask questions and will be reminded of the voluntary nature of their participation prior to signing the informed consent form. Signed informed consents will be collected and securely stored in Dr. Duren's office. At this time, participants will also be given an additional copy of the informed consent for future reference. At the end of the intervention participants will be reconsented to participate in the interview process if they choose.
Number of Subjects Using G\*Power (V3.1) sample size calculations were completed using estimated and calculated effect sizes from previously published SSSH research 7-9. Estimated low and medium effect sizes resulted in a sample size ranging from 12-55. Calculated effect sizes for the 30 second sit to stand (balance), DXA (body composition), and the Self Administered Gerocognitive Examination (cognitive function) resulted in a sample size ranging from 9 to 43. The investigators believe nearly 50 participants total are needed to reach statistical power for this study; however, assuming 15% attrition rates, 60 participants (up to 20 per group) will be recruited for the study.
Study Procedures/Design/Treatment Plan Participants who chose to enroll will be required to provide approximately five hours minimum or up to seven hours maximum of their time total, in addition to intervention exercise activities. The first visit will consist of the initial screening form and the informed consent, followed by a facility tour, and familiarization of the testing procedures and will take one hour. The second and third visits are identical in procedure and time required and will consist of a urine sample, blood draw, anthropometrics, DXA scans, and functional performance assessments, and questionnaires. These two visits lasting 2 hours each will occur immediately before and after the eight week intervention period. The last potential visit will be for follow-up interviews. Each visit and all questionnaires and procedures are explained in greater detail below.
Potential Risks/Adverse Events
The research team has taken extensive measures to reduce risk and the potential for adverse events. Both participant and research staff safety are a priority. The investigators will minimize these risk by taking the following precautions:
* Standard aseptic technique will be used for drawing blood and only trained personnel will complete blood sample, DXA scans, and functional testing.
* This research does not involve vulnerable populations and the investigators are not collecting any highly sensitive personal or medical information (e.g. social security numbers, banking information, HIPAA information) and do not expect any of the collected data to impact a participant's employment, insurability, social status, or reputation if it were to become public.
* Subjects' information will be coded and will be stored on University of Missouri secure database and the investigators will follow a strict protocol to ensure patient confidentiality at all times.
* Subjects are asked to perform balance assessment tests close to a wall under the supervision of trained personnel to avoid falls. Trained research staff will always be within reach to aid a participant if they lose their balance. Participants will never be left alone to complete a task.
During follow-up interviews, audio recording will be used for data collection. We will request that participants not identify anyone during their interview and the transcriptions of the audio recordings will be de-identified if participants do not heed our request. During the interview, participants may become tired from answering questions and talking or become frustrated by difficulty communicating as you want. The interviewer will listen to the participant closely and carefully and ask him/her to let her know if they become uncomfortable during the study and offer the participant breaks, as needed.
Any serious adverse events will be reported directly to the IRB, please see the Data Safety Monitoring Plan below for more details. In case of emergency, the electromyography, dual x-ray absorptiometry, or blood drawing process will be immediately stopped. The investigators will dial 911 in the case of emergency.
Anticipated Benefits Potential benefits experienced by the participant include: decreased risk of fall and frailty; improve sleep and cognition; increased muscle mass and strength; and improvements in bone turnover rates. Potential benefits to society include the curbing of the declining physical and mental capacity among seniors, which are key risk factors for falls. Strength training has been shown to mitigate these factors in seniors, ultimately saving the healthcare system billions of dollars in associated costs. Participants may gain a sense of accomplishment for helping us better understand the impact of the Stay Strong, Stay Healthy program.
Costs The costs for this study and procedures will be paid through internal departmental grant funding through the Department of Nutrition and Exercise Physiology, University of Missouri-Extension, and the Missouri Orthopaedic Institute.
Data Safety Monitoring Plan In order to protect the participants' personal information, data, and right to privacy this research team will take extensive precautions to maintain confidentiality. After the participant has cleared the initial screening forms and signed the informed consent all remaining surveys, questionnaires, DXA results, blood samples, and data sheets will only contain the participant' identification code. The key linking names and participant identification codes will be accessible to Dr. Dana Duren and she will only share the key with the research team once unblinding is necessary. All paper records will be kept in a locked filing cabinet in Dr. Duren's MU office (she is a Professor and Director of Orthopaedic Research and is familiar with handling confidential documents). Computerized records of experimental data will be similarly coded and will be maintained on a password protected MU secure computer. Copies of signed consent forms, as well as the experimental log book, are kept in a locked file cabinet in Dr. Duren's office. Participants will not be individually identified in any publications.
Additionally, all adverse events and/or unanticipated problems will be evaluated by Drs. Duren, Ball, and Baker as they occur, for subject safety and appropriate follow-up assessment, treatment, or care. All adverse events and/or unanticipated problems will be evaluated and assessed to answer the following questions: Is the event unexpected? Is the event related or possibly related to participation in the research? Does the event suggest that the research places subjects or others at a greater risk of harm than previously known or recognized? If all three answers are "yes", the event will be reported to the IRB within 5 days of the investigator becoming aware of the event. While reviewing each event, the PI(s) will determine if it is safe for the subject to continue participating in the trial and if it is safe to continue enrollment and research activity for all subjects.
Multiple Sites University of Missouri is the only site where research activities will occur. All required approvals are in order for the three specific rooms where data will be collected and analyzed.
The primary objective of the quantitative part of the research study is to track physiologic changes and determine the effectiveness of the SSSH exercise intervention in older adults. Participant's balance, gait, muscle strength, body composition, and skeletal health will be compared to a walking group and to a sedentary control group prior to and immediately following the eight week exercise intervention.
Participant centered objectives include:
* Participants will improve their balance, thus reducing their risk for falls.
* Participants will increase their muscle strength and improve body composition.
* Participants will increase their rate of bone formation.
* Participants will improve their cognition and sleep habits.
* Participants will increase their physical activity
The primary objective of the qualitative part of the research study is to explore perceptions of the impact of physical activity and changes in behaviors and attitudes of participants who completed the intervention period. The sequential approach of this study will (1) explore the effects of participating in the Stay Strong, Stay Healthy study that were difficult to measure quantitatively and (2) help interpret the quantitative findings and understanding.
Topics that will guide the qualitative study include participants':
* Concerns, motivations/benefits, and needs/barriers to physical activity
* Perceptions of social influences on physical activity
* Perceptions of impact of physical activity on psychological and emotional well-being, cognition, and sleep
* Perceptions of confidence related to fear of falling
* Perceptions of changes in behaviors and attitudes based on bone density test results
Recruitment Process The Stay Strong, Stay Healthy program is conducted throughout the state of Missouri. Class sessions are advertised by posting flyers and in newspapers. At the University of Missouri-Columbia, the SSSH program is advertised by posting flyers around campus and utilizing the email group for retired MU employees. Dr. Baker and research staff will also present the research study participation opportunity at pre SSSH sessions in Columbia and surrounding areas. The investigators will be available to answer questions via email and phone for any potential participants prior to their first visit on campus. The inclusion and exclusion criteria listed below in addition to the PAR-Q form will make up the initial screening form. During the recruitment process research staff will use this form to quickly screen potential participants for overt exclusion criteria, thus reducing the number of "screen failure" participants who will have to coordinate travel to campus for the first consenting visit. No personal health information is contained in these forms and all questions are yes/no, and this data will only be recorded for screening failures to inform selection bias. The inclusion of this form is purely the research team's attempt to reduce patient burden as travel can be very difficult for this patient population.
Consent Process Only research staff cleared to obtain written consent will escort participants to a private room in Gwynn Hall, where all screening and consenting will take place. After participants have cleared the initial screening checklist (the PAR-Q form and inclusion/exclusion criteria), research staff will deliberately and clearly explain each aspect of the informed consent. Participants will be encouraged to ask questions and will be reminded of the voluntary nature of their participation prior to signing the informed consent form. Signed informed consents will be collected and securely stored in Dr. Duren's office. At this time, participants will also be given an additional copy of the informed consent for future reference. At the end of the intervention participants will be reconsented to participate in the interview process if they choose.
Number of Subjects Using G\*Power (V3.1) sample size calculations were completed using estimated and calculated effect sizes from previously published SSSH research 7-9. Estimated low and medium effect sizes resulted in a sample size ranging from 12-55. Calculated effect sizes for the 30 second sit to stand (balance), DXA (body composition), and the Self Administered Gerocognitive Examination (cognitive function) resulted in a sample size ranging from 9 to 43. The investigators believe nearly 50 participants total are needed to reach statistical power for this study; however, assuming 15% attrition rates, 60 participants (up to 20 per group) will be recruited for the study.
Study Procedures/Design/Treatment Plan Participants who chose to enroll will be required to provide approximately five hours minimum or up to seven hours maximum of their time total, in addition to intervention exercise activities. The first visit will consist of the initial screening form and the informed consent, followed by a facility tour, and familiarization of the testing procedures and will take one hour. The second and third visits are identical in procedure and time required and will consist of a urine sample, blood draw, anthropometrics, DXA scans, and functional performance assessments, and questionnaires. These two visits lasting 2 hours each will occur immediately before and after the eight week intervention period. The last potential visit will be for follow-up interviews. Each visit and all questionnaires and procedures are explained in greater detail below.
Potential Risks/Adverse Events
The research team has taken extensive measures to reduce risk and the potential for adverse events. Both participant and research staff safety are a priority. The investigators will minimize these risk by taking the following precautions:
* Standard aseptic technique will be used for drawing blood and only trained personnel will complete blood sample, DXA scans, and functional testing.
* This research does not involve vulnerable populations and the investigators are not collecting any highly sensitive personal or medical information (e.g. social security numbers, banking information, HIPAA information) and do not expect any of the collected data to impact a participant's employment, insurability, social status, or reputation if it were to become public.
* Subjects' information will be coded and will be stored on University of Missouri secure database and the investigators will follow a strict protocol to ensure patient confidentiality at all times.
* Subjects are asked to perform balance assessment tests close to a wall under the supervision of trained personnel to avoid falls. Trained research staff will always be within reach to aid a participant if they lose their balance. Participants will never be left alone to complete a task.
During follow-up interviews, audio recording will be used for data collection. We will request that participants not identify anyone during their interview and the transcriptions of the audio recordings will be de-identified if participants do not heed our request. During the interview, participants may become tired from answering questions and talking or become frustrated by difficulty communicating as you want. The interviewer will listen to the participant closely and carefully and ask him/her to let her know if they become uncomfortable during the study and offer the participant breaks, as needed.
Any serious adverse events will be reported directly to the IRB, please see the Data Safety Monitoring Plan below for more details. In case of emergency, the electromyography, dual x-ray absorptiometry, or blood drawing process will be immediately stopped. The investigators will dial 911 in the case of emergency.
Anticipated Benefits Potential benefits experienced by the participant include: decreased risk of fall and frailty; improve sleep and cognition; increased muscle mass and strength; and improvements in bone turnover rates. Potential benefits to society include the curbing of the declining physical and mental capacity among seniors, which are key risk factors for falls. Strength training has been shown to mitigate these factors in seniors, ultimately saving the healthcare system billions of dollars in associated costs. Participants may gain a sense of accomplishment for helping us better understand the impact of the Stay Strong, Stay Healthy program.
Costs The costs for this study and procedures will be paid through internal departmental grant funding through the Department of Nutrition and Exercise Physiology, University of Missouri-Extension, and the Missouri Orthopaedic Institute.
Data Safety Monitoring Plan In order to protect the participants' personal information, data, and right to privacy this research team will take extensive precautions to maintain confidentiality. After the participant has cleared the initial screening forms and signed the informed consent all remaining surveys, questionnaires, DXA results, blood samples, and data sheets will only contain the participant' identification code. The key linking names and participant identification codes will be accessible to Dr. Dana Duren and she will only share the key with the research team once unblinding is necessary. All paper records will be kept in a locked filing cabinet in Dr. Duren's MU office (she is a Professor and Director of Orthopaedic Research and is familiar with handling confidential documents). Computerized records of experimental data will be similarly coded and will be maintained on a password protected MU secure computer. Copies of signed consent forms, as well as the experimental log book, are kept in a locked file cabinet in Dr. Duren's office. Participants will not be individually identified in any publications.
Additionally, all adverse events and/or unanticipated problems will be evaluated by Drs. Duren, Ball, and Baker as they occur, for subject safety and appropriate follow-up assessment, treatment, or care. All adverse events and/or unanticipated problems will be evaluated and assessed to answer the following questions: Is the event unexpected? Is the event related or possibly related to participation in the research? Does the event suggest that the research places subjects or others at a greater risk of harm than previously known or recognized? If all three answers are "yes", the event will be reported to the IRB within 5 days of the investigator becoming aware of the event. While reviewing each event, the PI(s) will determine if it is safe for the subject to continue participating in the trial and if it is safe to continue enrollment and research activity for all subjects.
Multiple Sites University of Missouri is the only site where research activities will occur. All required approvals are in order for the three specific rooms where data will be collected and analyzed.
Conditions
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Frail Elderly
Sedentary Lifestyle
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Participants will be randomized into three groups of equal size. The experimental group (Stay Strong, Stay Healthy strength training program), the walking exercise group, and the sedentary control group will participate in the trial in parallel for up to ten weeks. After the intervention period, participants from each group will have the opportunity to participate in an interview about their experiences.
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Investigators
Outcome Assessors
The primary investigator (Dr. Duren) will randomize participants into each of the three study groups. The research team responsible for assessments and analysis will be blinded to each participant's assignment. Dr. Duren will unblind the research team after the intervention period and data collection and analysis has been completed.
Study Groups
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Stay Strong, Stay Healthy Group
The Stay Strong, Stay Healthy strength training group will meet two times per week for an hour, for eight consecutive weeks. This class provides participants a structured program to learn and progress through strength training exercises designed to increase overall fitness, flexibility, and balance.
Group Type
EXPERIMENTAL
Exercise
Intervention Type
BEHAVIORAL
Exercise is a behavioral intervention, the primary aim of this investigation is to elucidate if strength training is a more effective exercise intervention than walking for the improvement of balance in older adults.
Walking Group
The walking group will meet two times per week for an hour, for eight consecutive weeks. This class provides participants a structured walking program to help delineate the effects of the strength training program and exercise in general.
Group Type
ACTIVE_COMPARATOR
Exercise
Intervention Type
BEHAVIORAL
Exercise is a behavioral intervention, the primary aim of this investigation is to elucidate if strength training is a more effective exercise intervention than walking for the improvement of balance in older adults.
Delayed Start Group
The delayed start group will not make any changes to their sedentary lifestyle and will be encouraged to not begin any exercise programs throughout the duration of the study.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Exercise
Exercise is a behavioral intervention, the primary aim of this investigation is to elucidate if strength training is a more effective exercise intervention than walking for the improvement of balance in older adults.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Are male or female ≥60 years of age
* Are sedentary (no strength training and \<30min/wk of other physical activity in the past 3 months)
* Are ambulatory (cane or walker permitted)
* Are free from current physical injury or illness preventing physical activity
* Are sedentary (no strength training and \<30min/wk of other physical activity in the past 3 months)
* Are ambulatory (cane or walker permitted)
* Are free from current physical injury or illness preventing physical activity
Exclusion Criteria
* Answered YES to two or more questions on the PAR-Q form
* Are female subjects who have not fully gone through menopause
* Were a previous SSSH participant
* Have dementia/Alzheimer's or other cognitive impairments that would limit ability to follow directions
* Are female subjects who have not fully gone through menopause
* Were a previous SSSH participant
* Have dementia/Alzheimer's or other cognitive impairments that would limit ability to follow directions
Minimum Eligible Age
60 Years
Maximum Eligible Age
100 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Dana Duren
OTHER
Sponsor Role
lead
Responsible Party
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Dana Duren
Professor and Director of Orthopaedic Research at the Missouri Orthopaedic Institute
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Dana L Duren, PhD
Role: PRINCIPAL_INVESTIGATOR
Director of Orthopaedic Research at the University of Missouri
Locations
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University of Missouri
Columbia, Missouri, United States
Site Status
Countries
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United States
References
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Seguin RA, Economos CD, Hyatt R, Palombo R, Reed PN, Nelson ME. Design and national dissemination of the StrongWomen Community Strength Training Program. Prev Chronic Dis. 2008 Jan;5(1):A25. Epub 2007 Dec 15.
Reference Type
BACKGROUND
Seguin RA, Folta SC, Nelson ME, Hanson KL, LaCroix AZ. Long-Term Body Weight Maintenance among StrongWomen-Healthy Hearts Program Participants. J Environ Public Health. 2017;2017:4372048. doi: 10.1155/2017/4372048. Epub 2017 Mar 2.
Reference Type
BACKGROUND
Guizelini PC, de Aguiar RA, Denadai BS, Caputo F, Greco CC. Effect of resistance training on muscle strength and rate of force development in healthy older adults: A systematic review and meta-analysis. Exp Gerontol. 2018 Feb;102:51-58. doi: 10.1016/j.exger.2017.11.020. Epub 2017 Nov 28.
Reference Type
BACKGROUND
Foster C, Armstrong MEG. What types of physical activities are effective in developing muscle and bone strength and balance? J Frailty Sarcopenia Falls. 2018 Jun 1;3(2):58-65. doi: 10.22540/JFSF-03-058. eCollection 2018 Jun.
Reference Type
BACKGROUND
Beavers KM, Walkup MP, Weaver AA, Lenchik L, Kritchevsky SB, Nicklas BJ, Ambrosius WT, Stitzel JD, Register TC, Shapses SA, Marsh AP, Rejeski WJ. Effect of Exercise Modality During Weight Loss on Bone Health in Older Adults With Obesity and Cardiovascular Disease or Metabolic Syndrome: A Randomized Controlled Trial. J Bone Miner Res. 2018 Dec;33(12):2140-2149. doi: 10.1002/jbmr.3555. Epub 2018 Aug 7.
Reference Type
BACKGROUND
Northey JM, Cherbuin N, Pumpa KL, Smee DJ, Rattray B. Exercise interventions for cognitive function in adults older than 50: a systematic review with meta-analysis. Br J Sports Med. 2018 Feb;52(3):154-160. doi: 10.1136/bjsports-2016-096587. Epub 2017 Apr 24.
Reference Type
BACKGROUND
Syed-Abdul, M.M., Peterson, E.C., Mills-Gray, S.L., Parks, E.J. & Ball, S.D. Stay Strong, Stay Healthy: University of Missouri-Extension's Strength-Training Program for Older Adults in Community Settings. Med Sci Sports Exer 48:5, 125-125 (2016).
Reference Type
BACKGROUND
Crowe EM, Ball SD. Effectiveness of Advanced Stay Strong, Stay Healthy in Community Settings. Gerontol Geriatr Med. 2015 Aug 3;1:2333721415596462. doi: 10.1177/2333721415596462. eCollection 2015 Jan-Dec.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Baker BS, Weitzel KJ, Royse LA, Miller K, Guess TM, Ball SD, Duren DL. Efficacy of an 8-Week Resistance Training Program in Older Adults: A Randomized Controlled Trial. J Aging Phys Act. 2021 Feb 1;29(1):121-129. doi: 10.1123/japa.2020-0078. Epub 2020 Aug 12.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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https://extension2.missouri.edu/programs/stay-strong-stay-healthy
The home SSSH link
Other Identifiers
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2014256
Identifier Type: -
Identifier Source: org_study_id
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