Clinical trial NCT03990415: Stay Strong, Stay Healthy Outcomes in Older Adults
Official title: Physical Function in Older Adults in the Stay Strong, Stay Healthy Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly
Sedentary Lifestyle
Keywords: Elderly
Balance
Strength Training
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 52
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Change in Balance During a Dynamic Task Using Force Plates.
timeFrame: Baseline and at end of intervention period, typically 8 weeks.
measure: Change in Balance During a Static Task Using Force Plates.
timeFrame: Baseline and at end of intervention period, typically 8 weeks.
Secondary outcomes:
measure: Changes in Grip Strength Using a Hand Dynamometer.
timeFrame: Baseline and at end of intervention period, typically 8 weeks.
measure: Changes in Walking Speed Using a 10 Meter Course.
timeFrame: Baseline and at end of intervention period, typically 8 weeks.
measure: Changes in the Timed Up and Go
timeFrame: Baseline and at end of intervention period, typically 8 weeks.
measure: Changes in Upper Body Muscle Flexibility Using the Back Scratch Test.
timeFrame: Baseline and at end of intervention period, typically 8 weeks.
measure: Changes in Lower Body Muscle Flexibility Using the Sit and Reach Test.
timeFrame: Baseline and at end of intervention period, typically 8 weeks.
measure: Changes in Sleep Quality Using the Pittsburgh Sleep Quality Index Test.
timeFrame: Baseline and at end of intervention period, typically 8 weeks.
measure: Changes in Cognition Performance Using the Self Administered Gerocognitive Examination.
timeFrame: Baseline and at end of intervention period, typically 8 weeks.
measure: Changes in Bone Activity Using the Ratio of Serum Bone Turnover Markers (PINP ng/mL and CTX ng/mL).
timeFrame: Baseline and at end of intervention period, typically 8 weeks.
measure: Changes is Bone Mineral Density T-scores
timeFrame: Baseline and at end of intervention period, typically 8 weeks.
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: Director of Orthopaedic Research at the University of Missouri
name: Dana L Duren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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).
citation: 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.
citation: 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.
citation: 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.