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

NCT04681794 | Completed

• 1 other identifier: 20-001520
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Aging

Outcome Measures

Primary Outcomes (27)

• Change from baseline demographic information at 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.)

  baseline, 12 weeks

• Change from baseline frailty index information at 12 weeks, 1

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

  baseline, 12 weeks

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

  • International Knee Documentation Committee Subjective Knee Evaluation

  baseline, 12 weeks

• Changes from baseline psychological assessment at 12 weeks, 1

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

  baseline, 12 weeks

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

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

  baseline, 12 weeks

• Changes from baseline hand-Grip Strength at 12 weeks

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

  baseline, 12 weeks

• Changes from baseline walking speed at 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.

  baseline, 12 weeks

• Changes from baseline knee strength at 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).

  baseline, 12 weeks

• Changes from baseline knee muscular steadiness at 12 weeks

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

  baseline, 12 weeks

• Changes from baseline balance at 12 weeks

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

  baseline, 12 weeks

• Changes from baseline posture at 12 weeks

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

  baseline, 12 weeks

• Changes from baseline heel bone ultrasound scan at 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.

  baseline, 12 weeks

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

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

  baseline, 12 weeks

• Changes from baseline frailty index at 12 weeks, 2

  • A multi-domain frailty assessment

  baseline, 12 weeks

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

  • Knee Osteoarthritis Outcome Score

  baseline, 12 weeks

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

  • Knee Outcome Survey-Activities of Daily Living

  baseline, 12 weeks

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

  • Global Rating score

  baseline, 12 weeks

• Changes from baseline psychological assessment at 12 weeks, 2

  • 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

  baseline, 12 weeks

• Changes from baseline psychological assessment at 12 weeks, 3

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

  baseline, 12 weeks

• Changes from baseline psychological assessment at 12 weeks, 4

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

  baseline, 12 weeks

• Changes from baseline psychological assessment at 12 weeks, 5

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

  baseline, 12 weeks

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

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

  baseline, 12 weeks

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

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

  baseline, 12 weeks

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

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

  baseline, 12 weeks

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

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

  baseline, 12 weeks

• Knee Flexion and Extension Visual-Motor Reaction Time

  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.

  baseline, after 12 weeks

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

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

  baseline, 12 weeks

Study Arms (2)

MayoP4 Group

EXPERIMENTAL

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

Other: exercise-based intervention

Control Group

NO INTERVENTION

No intervention

Interventions

exercise-based intervention OTHER

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

Also known as: MayoP4

MayoP4 Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Takashi Nagai, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: December 23, 2020
• Study Start: December 14, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)