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Completed

NCT Number: NCT04681794

Mayo Posture Positivity Power Program for Active and Aging Individuals in Communities

The research is designed to answer effectiveness of community-based multimodal intervention programs on physical, mental, cognitive, social, and environmental in active and aging individuals.

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Key information

Conditions

Healthy Aging

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

Despite that musculoskeletal diseases/conditions are the leading cause of disability and frailty/mortality in aging individuals, the musculoskeletal health is given little consideration. Exercise is essential and effective publicly-available medicine for management/prevention of obesity, lack of physical activity, chronic disease, frailty, and mental stress/anxiety/depression without any side-effects from drug use/abuse.

More recently, multimodal interventions with physical, postural, mindfulness, and power exercises have shown to be effective improving both physical and mental health. To expand the recent trend in multimodal intervention, the current proposal will examine effects of community-based multimodal intervention on physical, psychological, cognitive, social, and environmental characteristics in aging individuals. Simultaneously, a cross-sectional study will establish normative values and inter-relationships.

One simple (15 minutes a day /2-3 times a week) yet comprehensive multimodal (balance, posture/thoracic spine, hopping, and mindfulness) intervention could provide a practical solution for aging individuals. Such a program could be implemented individually or by community staff, which would allow for a large-scale community implementation.

Therefore, the overall objective of the project is to explore effects of a community-based, simple, multimodal intervention program (MayoP4) for aging individuals. A small group intervention with friends and club/family members will help peer-to-peer support/team spirit and improve positive engagement.

The secondary objective of this project is to establish normative values and examine interrelations among various frailty/mortality risk factors. In addition to physical activity, musculoskeletal, balance/posture, and psychological/wellness factors, there are many additional elements associated with frailty/mortality risk. These include, but are not limited to, positive thinking/behavior (optimism), sufficient sleep, and cognitive/social/environmental considerations. Physical frailty plays an important role and positively influences all other domains; however, this relationship among aging individuals in our communities remains to be established.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be physically capable (defined as easy to moderate physical activities daily at least 60 minutes).
  • Participants also must have a normal (18.5-24.9kg/m2) or overweight BMI (25-29.9kg/m2).
  • Participants must be able to speak, listen, read, and understand sentences written in English.

Exclusion criteria

  • Participants who display more than two risk factors for coronary artery disease
  • Participants who have a history of falls, osteoporosis, osteoarthritis, or orthopedic or neurological conditions (i.e., stroke)
  • Participants who take medications that cause dizziness or slow movement
  • Participants who smoke
  • Participants who have a body mass to height squared ratio greater than 30kg/m2 or less than 18.4kg/m2, blood pressure greater than 140/90 mmHg, or a history of heart conditions.

Treatment and study plan

exercise-based intervention

Other

MayoP4 is a 15-minute warmup with 4 different components of exercise: balance, posture, jumping/hopping, and movement-based mindfulness.

Other names: MayoP4

Primary outcomes

  1. Change from baseline demographic information at 12 weeks

    Time frame: baseline, 12 weeks

    • Age (continuous),
    • Race (White, Black, Asian, Pacific Islander, Hispanic/Latino, American Indian)
    • Marital Status (married, divorced/separated/single, widowed)
    • Education (less than High School, High School, College, Graduate School)
    • Height
    • Weight
    • Smoking (never, former, current)
    • Alcohol (intake from wine, beer, and liquor - none, 1-14g/day, >15g/day.)
    • For Women Only: Women health questions will be asked for past/present conditions (pregnancy, hormonal treatment, menopause, supplements, medications, etc.)

  2. Change from baseline frailty index information at 12 weeks, 1

    Time frame: baseline, 12 weeks

    • Comprehensive Frailty Assessment Instrument Plus: Assessment of frailty in physical, psychological, social, cognitive, and environmental domains

  3. Change from baseline Knee/Osteoarthritis Self-Reported Questionnaires at 12 weeks, 1

    Time frame: baseline, 12 weeks

    • International Knee Documentation Committee Subjective Knee Evaluation

  4. Changes from baseline psychological assessment at 12 weeks, 1

    Time frame: baseline, 12 weeks

    • Perceived Stress Scale: A 14-item self-report tool that provides a global measure of perceived stress

  5. Changes from baseline overall health surveys / physical frailty test at 12 weeks, 1

    Time frame: baseline, 12 weeks

    • Medical Outcomes Study 36-Item Short-Form Health Survey: A common medical questionnaire for general health and wellbeing

  6. Changes from baseline hand-Grip Strength at 12 weeks

    Time frame: baseline, 12 weeks

    A standard handgrip isometric strength test performed using a Jamar Hydraulic Hand Dynamometer.

  7. Changes from baseline walking speed at 12 weeks

    Time frame: baseline, 12 weeks

    you will be asked to walk as fast as you can for 4-meter (12 feet) three times. 4-meter distance will be marked with a tape.

  8. Changes from baseline knee strength at 12 weeks

    Time frame: baseline, 12 weeks

    A custom-built knee strength measuring device will examine your quadriceps muscles (front muscles of the thigh) and hamstrings muscles (back muscles of the thigh).

  9. Changes from baseline knee muscular steadiness at 12 weeks

    Time frame: baseline, 12 weeks

    • Force steadiness test will assess individual's ability to hold their muscular force for 10 seconds steady.

  10. Changes from baseline balance at 12 weeks

    Time frame: baseline, 12 weeks

    Standing balance with eyes-open and eyes-closed will be tested.

  11. Changes from baseline posture at 12 weeks

    Time frame: baseline, 12 weeks

    standard 2D camera will be used to assess standing posture and overhead squatting posture.

  12. Changes from baseline heel bone ultrasound scan at 12 weeks

    Time frame: baseline, 12 weeks

    Quantitative ultrasound is accurate, inexpensive, and portable alternative to DXA bone mineral density. This device will measure the speed of sound and the frequency-dependent attenuation of the sound waves to calculate the stiffness index which is equivalent to bone mineral density.

  13. Changes from baseline ultrasound-based bilateral anterior thigh thickness at 12 weeks

    Time frame: baseline, 12 weeks

    A diagnostic musculoskeletal ultrasound will be used to measure your thigh muscle size.

  14. Changes from baseline frailty index at 12 weeks, 2

    Time frame: baseline, 12 weeks

    • A multi-domain frailty assessment

  15. Changes from baseline knee/osteoarthritis self-reported questionnaires at 12 weeks, 2

    Time frame: baseline, 12 weeks

    • Knee Osteoarthritis Outcome Score

  16. Changes from baseline knee/osteoarthritis self-reported questionnaires at 12 weeks, 3

    Time frame: baseline, 12 weeks

    • Knee Outcome Survey-Activities of Daily Living

  17. Changes from baseline knee/osteoarthritis self-reported questionnaires at 12 weeks, 4

    Time frame: baseline, 12 weeks

    • Global Rating score

  18. Changes from baseline psychological assessment at 12 weeks, 2

    Time frame: baseline, 12 weeks

    • Generalized Anxiety Disorder 7-item: A 7-item questionnaire which asks how often, during the last 2 weeks, the participant was bothered by anxiety-related symptoms

  19. Changes from baseline psychological assessment at 12 weeks, 3

    Time frame: baseline, 12 weeks

    • Mindfulness Attention Awareness Scale: A 15-item measure assessing mindfulness of moment to moment experience

  20. Changes from baseline psychological assessment at 12 weeks, 4

    Time frame: baseline, 12 weeks

    • Patient Health Questionnaire-9: A self-administered tool for assessing depression

  21. Changes from baseline psychological assessment at 12 weeks, 5

    Time frame: baseline, 12 weeks

    • Optimism. Revised Life Orientation Test: A questionnaire to assess individual's optimism and related to healthy aging seniors

  22. Changes from baseline overall health surveys / physical frailty test at 12 weeks, 2

    Time frame: baseline, 12 weeks

    • Barthel Index of Activities of Daily Living: A 10-item questionnaire for activities of daily living

  23. Changes from baseline overall health surveys / physical frailty test at 12 weeks, 3

    Time frame: baseline, 12 weeks

    • Pittsburgh Sleep Quality Index: A self-reported questionnaire that assesses sleep quality and disturbances

  24. Changes from baseline overall health surveys / physical frailty test at 12 weeks, 4

    Time frame: baseline, 12 weeks

    • Sarcopenia Questionnaire: This questionnaire will ask participants basic physical capability

  25. Changes from baseline overall health surveys / physical frailty test at 12 weeks, 5

    Time frame: baseline, 12 weeks

    • Mini Nutritional Assessment - Short Form: Assesses malnutrition, weight loss, and a lack of appetite

  26. Knee Flexion and Extension Visual-Motor Reaction Time

    Time frame: baseline, after 12 weeks

    Subjects will be asked to kick up (quadriceps - knee extensors) or pull back (hamstrings - knee flexors) as soon as an arrow is displaced up or down, respectively.

  27. Changes from baseline ultrasound-based bilateral anterior thigh muscle stiffness measurements at 12 weeks

    Time frame: baseline, 12 weeks

    Ultrasound probe will be placed at the mid-thigh (the quadriceps) during rest and knee extension strength force steadiness testing.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Mayo Posture Positivity Power Program (MayoP4) for Active and Aging Individuals in Communities

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 23, 2020
Registry last updated
Dec 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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