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临床试验/NCT04681794
NCT04681794已完成不适用

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

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2020年12月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
59
试验地点
1
主要终点
Changes from baseline overall health surveys / physical frailty test at 12 weeks, 3

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

MayoP4 Group

Experimental

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

干预措施: exercise-based intervention (Other)

Control Group

No Intervention

No intervention

结局指标

主要结局

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

时间窗: baseline, 12 weeks

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

Changes from baseline knee strength at 12 weeks

时间窗: 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).

Change from baseline demographic information at 12 weeks

时间窗: 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.)

Changes from baseline psychological assessment at 12 weeks, 1

时间窗: 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

时间窗: baseline, 12 weeks

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

Changes from baseline balance at 12 weeks

时间窗: baseline, 12 weeks

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

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

时间窗: baseline, 12 weeks

• Knee Osteoarthritis Outcome Score

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

时间窗: baseline, 12 weeks

• Global Rating score

Changes from baseline psychological assessment at 12 weeks, 2

时间窗: 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

时间窗: baseline, 12 weeks

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

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

时间窗: baseline, 12 weeks

• International Knee Documentation Committee Subjective Knee Evaluation

Changes from baseline hand-Grip Strength at 12 weeks

时间窗: baseline, 12 weeks

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

Changes from baseline knee muscular steadiness at 12 weeks

时间窗: baseline, 12 weeks

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

Change from baseline frailty index information at 12 weeks, 1

时间窗: baseline, 12 weeks

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

Changes from baseline walking speed at 12 weeks

时间窗: 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 heel bone ultrasound scan at 12 weeks

时间窗: 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 knee/osteoarthritis self-reported questionnaires at 12 weeks, 3

时间窗: baseline, 12 weeks

• Knee Outcome Survey-Activities of Daily Living

Changes from baseline posture at 12 weeks

时间窗: baseline, 12 weeks

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

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

时间窗: baseline, 12 weeks

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

Changes from baseline psychological assessment at 12 weeks, 4

时间窗: baseline, 12 weeks

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

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

时间窗: baseline, 12 weeks

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

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

时间窗: 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

时间窗: baseline, 12 weeks

• A multi-domain frailty assessment

Knee Flexion and Extension Visual-Motor Reaction Time

时间窗: 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 psychological assessment at 12 weeks, 5

时间窗: baseline, 12 weeks

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

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

时间窗: baseline, 12 weeks

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

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

时间窗: baseline, 12 weeks

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

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Takashi Nagai

Principal Investigator

Mayo Clinic

研究点 (1)

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