Healthy AgingNCT04681794
Mayo Posture Positivity Power Program for Active and Aging Individuals in Communities
A study testing exercise-based intervention in people with Healthy Aging, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- exercise-based intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2020to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mayo Posture Positivity Power Program (MayoP4) 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.
Read the 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.
- Conditions
- Healthy Aging
- Being tested
- exercise-based intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise-based interventionOther
Also called MayoP4
MayoP4 is a 15-minute warmup with 4 different components of exercise: balance, posture, jumping/hopping, and movement-based mindfulness.
| Study group | Role | What they receive |
|---|---|---|
| MayoP4 Group | Experimental | MayoP4 is a 15-minute warmup with 4 different components of exercise: balance, posture, hopping/jumping, and movement-based mindfulness. Receives: Other: exercise-based intervention |
| Control Group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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
Measured: baseline, 12 weeks
Change from baseline Knee/Osteoarthritis Self-Reported Questionnaires at 12 weeks, 1
- International Knee Documentation Committee Subjective Knee Evaluation
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: baseline, 12 weeks
Changes from baseline balance at 12 weeks
Standing balance with eyes-open and eyes-closed will be tested.
Measured: baseline, 12 weeks
Changes from baseline posture at 12 weeks
standard 2D camera will be used to assess standing posture and overhead squatting posture.
Measured: 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.
Measured: 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.
Measured: baseline, 12 weeks
Changes from baseline frailty index at 12 weeks, 2
- A multi-domain frailty assessment
Measured: baseline, 12 weeks
Changes from baseline knee/osteoarthritis self-reported questionnaires at 12 weeks, 2
- Knee Osteoarthritis Outcome Score
Measured: baseline, 12 weeks
Changes from baseline knee/osteoarthritis self-reported questionnaires at 12 weeks, 3
- Knee Outcome Survey-Activities of Daily Living
Measured: baseline, 12 weeks
Changes from baseline knee/osteoarthritis self-reported questionnaires at 12 weeks, 4
- Global Rating score
Measured: 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
Measured: 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
Measured: baseline, 12 weeks
Changes from baseline psychological assessment at 12 weeks, 4
- Patient Health Questionnaire-9: A self-administered tool for assessing depression
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start14 Dec 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takashi Nagai, Mayo Clinic
- Investigators
- Takashi Nagai, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681794
- Sponsor's protocol ID
- 20-001520
- Status last verified
- Dec 2021
- First submitted
- 21 Oct 2020
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mayo Posture Positivity Power Program (MayoP4) for Active and Aging Individuals in Communities
- ClinicalTrials.gov ID
- NCT04681794
- Acronym / sponsor ID
- 20-001520
- Conditions
- Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MayoP4 Group | Experimental | Other: exercise-based interventionMayoP4 is a 15-minute warmup with 4 different components of exercise: balance, posture, hopping/jumping, and movement-based mindfulness. |
| Control Group | No intervention | –No intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise-based interventionAlso: MayoP4MayoP4 is a 15-minute warmup with 4 different components of exercise: balance, posture, jumping/hopping, and movement-based mindfulness. | Other | MayoP4 Group |
Primary outcome
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.)
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
Change from baseline Knee/Osteoarthritis Self-Reported Questionnaires at 12 weeks, 1
Time frame: baseline, 12 weeks
• International Knee Documentation Committee Subjective Knee Evaluation
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
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
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.
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.
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).
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.
Changes from baseline balance at 12 weeks
Time frame: baseline, 12 weeks
Standing balance with eyes-open and eyes-closed will be tested.
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.
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.
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.
Changes from baseline frailty index at 12 weeks, 2
Time frame: baseline, 12 weeks
• A multi-domain frailty assessment
Changes from baseline knee/osteoarthritis self-reported questionnaires at 12 weeks, 2
Time frame: baseline, 12 weeks
• Knee Osteoarthritis Outcome Score
Changes from baseline knee/osteoarthritis self-reported questionnaires at 12 weeks, 3
Time frame: baseline, 12 weeks
• Knee Outcome Survey-Activities of Daily Living
Changes from baseline knee/osteoarthritis self-reported questionnaires at 12 weeks, 4
Time frame: baseline, 12 weeks
• Global Rating score
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
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
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
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
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
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
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
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takashi Nagai, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise-based intervention in people with Healthy Aging, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline demographic information at 12 weeks (time frame: baseline, 12 weeks). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.