Clinical trial NCT04681794: Mayo Posture Positivity Power Program for Active and Aging Individuals in Communities
Official title: Mayo Posture Positivity Power Program (MayoP4) for Active and Aging Individuals in Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Aging
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 59
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline demographic information at 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline frailty index information at 12 weeks, 1
timeFrame: baseline, 12 weeks
measure: Change from baseline Knee/Osteoarthritis Self-Reported Questionnaires at 12 weeks, 1
timeFrame: baseline, 12 weeks
measure: Changes from baseline psychological assessment at 12 weeks, 1
timeFrame: baseline, 12 weeks
measure: Changes from baseline overall health surveys / physical frailty test at 12 weeks, 1
timeFrame: baseline, 12 weeks
measure: Changes from baseline hand-Grip Strength at 12 weeks
timeFrame: baseline, 12 weeks
measure: Changes from baseline walking speed at 12 weeks
timeFrame: baseline, 12 weeks
measure: Changes from baseline knee strength at 12 weeks
timeFrame: baseline, 12 weeks
measure: Changes from baseline knee muscular steadiness at 12 weeks
timeFrame: baseline, 12 weeks
measure: Changes from baseline balance at 12 weeks
timeFrame: baseline, 12 weeks
measure: Changes from baseline posture at 12 weeks
timeFrame: baseline, 12 weeks
measure: Changes from baseline heel bone ultrasound scan at 12 weeks
timeFrame: baseline, 12 weeks
measure: Changes from baseline ultrasound-based bilateral anterior thigh thickness at 12 weeks
timeFrame: baseline, 12 weeks
measure: Changes from baseline frailty index at 12 weeks, 2
timeFrame: baseline, 12 weeks
measure: Changes from baseline knee/osteoarthritis self-reported questionnaires at 12 weeks, 2
timeFrame: baseline, 12 weeks
measure: Changes from baseline knee/osteoarthritis self-reported questionnaires at 12 weeks, 3
timeFrame: baseline, 12 weeks
measure: Changes from baseline knee/osteoarthritis self-reported questionnaires at 12 weeks, 4
timeFrame: baseline, 12 weeks
measure: Changes from baseline psychological assessment at 12 weeks, 2
timeFrame: baseline, 12 weeks
measure: Changes from baseline psychological assessment at 12 weeks, 3
timeFrame: baseline, 12 weeks
measure: Changes from baseline psychological assessment at 12 weeks, 4
timeFrame: baseline, 12 weeks
measure: Changes from baseline psychological assessment at 12 weeks, 5
timeFrame: baseline, 12 weeks
measure: Changes from baseline overall health surveys / physical frailty test at 12 weeks, 2
timeFrame: baseline, 12 weeks
measure: Changes from baseline overall health surveys / physical frailty test at 12 weeks, 3
timeFrame: baseline, 12 weeks
measure: Changes from baseline overall health surveys / physical frailty test at 12 weeks, 4
timeFrame: baseline, 12 weeks
measure: Changes from baseline overall health surveys / physical frailty test at 12 weeks, 5
timeFrame: baseline, 12 weeks
measure: Knee Flexion and Extension Visual-Motor Reaction Time
timeFrame: baseline, after 12 weeks
measure: Changes from baseline ultrasound-based bilateral anterior thigh muscle stiffness measurements at 12 weeks
timeFrame: baseline, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Takashi Nagai, PhD
role: PRINCIPAL_INVESTIGATOR
References: