Stay Strong, Stay Healthy Outcomes in Older Adults
Condition: Frail Elderly; Sedentary Lifestyle
Study type: Interventional

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.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Elderly; Balance; Strength Training