Golf for Veterans Study
Condition: Exercise Training
Study type: Interventional

Summary: 
      Aging is associated with physiological declines that could impair the ability to perform
      activities of daily living and thus impair the quality of life of older adults. Golf is an
      activity that challenges the balance, flexibility, and muscular systems of the golfer and
      could have important implications in addressing the physiological declines associated with
      aging. Golf also challenges the cognition of golfer and is typically performed in groups of
      2-4 people; therefore, it could also have important implications for the cognitive and social
      health of older adults. This research will investigate the effects of an introductory,
      therapeutic golf program on the physiological, cognitive, and social well-being of older
      adults. Older adult military veterans (60-80 years) will participate in a 12-week
      introductory golf program specifically designed with older adults in mind. The intervention
      will be led by Professional Golf Association (PGA) professionals with experience in teaching
      older adults to golf. In order to assess the effectiveness of the intervention, the
      functional, physiological, and cognitive abilities of the participants will be evaluated as
      well as the overall well-being before and after the completion of the golf program. These
      adaptations will be evaluated through the use of biomechanical analysis, standardized older
      adult functional tests, validated surveys and questionnaires, and validated cognitive
      assessments.
    

Detailed description: 
      Implementing a 12-week introductory golf intervention designed for older military veterans
      will allow us to evaluate the usefulness of golf as a means to promote physical activity and
      well-being across the lifespan. Golf, while studied from a performance perspective, has not
      been studied as an intervention to promote physical activity and health in older adults. This
      study will contribute to our knowledge about the feasibility and effectiveness of golf as a
      means to promote wellness across the lifespan.

      1.0 OBJECTIVES AND PURPOSE

      OBJECTIVE 1: Quantify the changes in the functional, cognitive, and physiological abilities
      of older military veterans following a 12-week introductory golf intervention.

      Hypothesis: Participants will demonstrate improved functional, cognitive and physiological
      abilities following the intervention.

      OBJECTIVE 2: Quantify golf demands and performance including a biomechanical analysis of golf
      swings, putting and picking up a ball following a 12-week introductory golf intervention.

      Hypothesis: The demands of the golf intervention will be similar to or greater than the
      demands during commonly utilized older adult balance and strengthening exercises.

      OBJECTIVE 3: Evaluate the safety and feasibility of a 12-week introductory golf intervention.

      Hypothesis 3A: Adverse events associated with the intervention will be minor and not more
      frequent than AE's associated with other activity programs in seniors.

      Hypothesis 3B: Adherence to the program will greater than the adherence associated with other
      activity-intervention programs in seniors.

      3.0 SELECTION AND WITHDRAWAL OF SUBJECTS

      Participants will be recruited using physician referrals, flyers, and visits to community
      centers, military Veteran fitness/wellness classes, military Veteran organizations, and
      military Veteran housing facilities in the Greater Los Angeles area. Once identified, the
      participants will go through a two-part screening process that includes a phone interview and
      clearance from their primary care physician. The phone screen includes the Telephone Memory
      Impairment Screen and a series of questions pertaining to the inclusion and exclusion
      criteria. Participants that pass the phone screen will be then required to receive clearance
      from their primary care physician prior to enrollment in the study. At the baseline testing
      session, additional details of the study will be explained to the participants, and consent
      obtained by an experienced researcher.

      4.0 RISK ANALYSIS The functional assessments include activities that are regularly conducted
      throughout the day and have been utilized regularly as part of common clinical practice for
      assessing functional abilities. In more challenging activities, the participants will be
      appropriately spotted to ensure safety during the test.

      The potential risks are as follows:

      Functional Assessment: Fatigue (very minimal risk) - Rest will be provided as needed for the
      participants.

      Muscle soreness (minimal risk) - This is no greater than performing normal activities of
      daily living.

      Joint or muscle injury (minimal risk) - This is no greater than performing normal activities
      of daily living.

      Risk of falling (minimal risk) - On the more challenging tasks, participants will be spotted.

      Cognitive Assessment: Questionnaires (minimal risk) - Participants will be given the option
      to skip or stop answering any questions that make them uncomfortable.

      Golf Intervention: Joint or muscle injury (minimal risk) - The participants will be gradually
      introduced to the activities associated with the sport of golf. Each golf session will
      include a sport specific warm-up and exercises that prepare the participants for the daily
      activities. Additionally, the golfers will be supervised by a PGA Professional who
      specializes in instructing older adults.

      Fatigue (very minimal risk) - Participants will also be allowed rest as needed.

      Adverse Events: Any unanticipated problem will be recorded via an incident report. Protocols
      for the USC MBRL have been developed. Any serious adverse event will be reported to the
      Institutional Review Board at the USC Health Science Campus using the flow chart below.

      Continual Safety Monitoring: Researchers will have weekly meetings with the PGA instructors
      to keep informed about the intervention and participant safety. Additionally, each week,
      research associates will check in with participants according to the Problem Reports and
      Tracking Problems Protocol.

      5.0 CLINICAL/LABORATORY EVALUATIONS AND STUDY CALENDAR

      Duration and Locations: The study from consent enrollment to final data collection will occur
      over a 16-week period. The study consists of two data collection visits to the Jacquelin
      Perry Musculoskeletal Biomechanics Research Laboratory (MBRL) in the Division of
      Biokinesiology and Physical Therapy located on the University of Southern California Health
      Science Campus and two data collection visits to a private room located at the West Los
      Angeles Veterans Administration Hospital (WLAVA). Day 1 (USC) and Day 2 (WLAVA) will occur
      following the consent enrollment (before training) and Day 3 (USC) and Day 4 (WLAVA) will
      occur following the completion of the training program.

      Biomechanical Analysis at USC (minimal risk): Laboratory kinematics and kinetics will be
      collecting using an 11-camera digital motion capture system (Qualysis, AB, Gothenberg,
      Sweden). 14 mm reflective markers will be used to define body segments and track motion
      during the trials. The trunk will be modeled as 2 rigid segments: pelvic and spine segments.
      The lower extremity will be modeled as 3 rigid segments: thigh, shank and foot.

      Day 1 Tasks (minimal risk): Data collection will last approximately 2 hours and will include
      previously validated functional assessments.

      Height, mass, resting heart rate, resting blood pressure and body fat percentage via
      Bioelectrical Impedance Analysis 6 minute walk test Hip muscle performance Gait analysis
      Modified Tandem Quiet Standing Balance confidence: Activities Specific Balance Confidence
      (ABC) Scale Participants will be given a Golf History Form to complete at home and return on
      Day 2

      Day 2 Tasks (minimal risk): Data collection will last approximately 1.5 hours and will
      include previously validated cognitive and self-efficacy assessments as well functional
      measures.

      Participants will turn in their Golf History Form Self-reported health-related quality of
      life as assessed by the RAND 12-item Health Survey Surveys from the Midlife in the United
      States Survey (MIDUS) study assessing Positive and Negative affect, Social Well-Being, and
      Sense of Control Cognition as assessed by the NIH Toolbox for cognition Physical activity
      habits will be assessed via a questionnaire developed by the Postmenopausal
      Estrogen/Progestins Intervention (PEPI) Study and a physical activity free recall Episodic
      verbal learning and memory as assessed by the California Verbal Learning Test Senior Fitness
      Test: 30-second chair stand and 8-foot-up-and-go test

      Day 3 Tasks (minimal risk): Data collection will last approximately 3 hours and will include
      all tasks performed on Day 1 plus a biomechanical analysis of golf-related demands (see
      below).

      Golf swings, chips and putts that are common to recreational golf players. Participants will
      perform up to 5-10 trials of each swing type.

      Picking up and setting down a golf ball. Subjects will perform up to 5-10 trials of each
      strategy.

      Exit questionnaire about golf training program

      Day 4 Tasks (minimal risk): Data collection will last approximately 2 hours and will include
      all tasks performed on Day 2.

      Six months after the completion of the study, participants will receive a telephone call to
      follow-up on their current golf playing habits following the 12-week program.

      Golf Training Visits: Participants will participate in golf training programs at the Heroes
      Golf Course on the WLAVA campus. Participants will be divided into groups of 2-4 golfers and
      will meet with a PGA Professional two times per week for 12 weeks. Training sessions will
      last 1-2 hours. The program is specifically designed for older adults not currently playing
      golf. The first set of sessions will include introduction to the different forms of the golf
      swing beginning with partial swings and then gradually progressing to a full swing. Swing
      modifications will be provided on an individual basis to address needs of the participant.
      Golf play will begin on holes that are flatter and close to the clubhouse and will begin by
      only playing 1-2 holes. The golfers will then be appropriately progressed to longer golf play
      as the PGA Professional feels it is appropriate. All equipment and fees will be included and
      there will be no cost to the participants.

      Tasks (minimal risk):

      Warm-up: Each training session will begin with a sport specific warm-up that prepares the
      participants for the activities of the day.

      Supplementary Exercises: Additional strengthening and flexibility exercises will be included
      in training sessions to prepare the participants for golf-related activities.

      Golf swings and putting: These movements will be introduced in a progressive nature beginning
      with partial swings of the least forceful swing type and eventually progressing to the more
      forceful swings (drives). Swings with the following equipment will be included: putters,
      pitching or sand wedges, irons, and woods.

      Picking up a ball: The participants will be introduced to techniques to picking up a golf
      ball which will be individualized to the needs of the participants based off current research
      in the MBRL (HS-15-00038).

      Walking: Participants will gradually increase walking distance. Practice will begin on flat
      holes and will progress to holes with more challenging terrain.

      Golf play: Participants will be gradually introduced to regular golf play beginning with play
      on a single, low difficulty hole and progressing to multiple holes. Skill difficulty will
      also be gradually increased.

      During the intervention, walking distance will be tracked via fitness trackers. Golf
      performance will be tracked as well.

      6.0 DATA COLLECTION AND MONITORING

      Data will be stored securely in the MBRL, CHP, room G9. Electronic data will be stored on a
      password protected computer. Hard copies of data will be stored in a locking file cabinet. No
      subject identifiers will be collected.

      7.0 STATISTICAL ANALYSIS 7.1 PRIMARY DEPENDENT VARIABLES

      7.1.1 Segment/joint angular positions, velocities, and accelerations 7.1.2 Joint torques
      7.1.3 COP dynamics 7.1.4 Static and dynamic balance 7.1.5 Hip Muscle Performance 7.1.6 Gait
      speed 7.1.7 Gait spatiotemporal characteristics 7.1.8 Cognitive-Motor Dual Task Performance
      7.1.9 Activities Specific Balance Confidence 7.1.10 Senior Fitness Test 7.1.11 Self-Rated
      Health 7.1.12 Verbal memory recall 7.1.13 Positive and Negative affect 7.1.14 Personal
      Mastery 7.1.15 Perceived Constraints 7.1.16 Social Contribution 7.1.17 Cognition Fluid
      Composition Score

      7.2 POWER ANALYSIS

      To date, this study has not been conducted and thus no preliminary data was available for a
      power analysis. 12 subjects are requested to ensure for adequate sample size and account for
      study attrition, based on other exercise intervention studies in older adults.

      7.3 STATISTICAL ANALYSIS Pre-Post comparisons will be made.

      8.0 REGISTRATION GUIDELINE

      Following confirmation of the inclusion and exclusion criteria, all potential participants
      will be consented before enrollment in the study. Study research associates have undergone
      CITI Training for human subjects' research. In order to participate in the study,
      participants must be English speaking and have the ability to follow instructions (as
      assessed by the Telephone Memory Impairment Screen); therefore, there is no need of a legally
      authorized representative during the consent process. Participants will be consented using a
      USC Informed Consent form after being explained the details of the study and allowing for
      adequate time to ask questions and make a decision.
    

Intervention name(s): golf training
Intervention type(s): Behavioral
Intervention description(s): 12 weeks of training by Professional Golf Association professional
Intervention model: Single Group Assignment
Intervention model description: Phase I, Feasibility and Safety Trial
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: aging, exercise, golf, intervention