Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG049369-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Institute on Aging (NIA) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this research is to examine the effects of four interventions on age-related cognitive decline in healthy older adults. The investigators will examine the effects of Mindfulness Based Stress Reduction (MBSR) psychotherapy, multi-component intensity-based aerobic exercise, and their combination, compared to a discussion group.
MBSR teaches mindfulness, or the focusing of attention and awareness, through various meditation techniques. Mindfulness meditation practices appear to produce neurocircuitry changes that are the reverse of those seen in age-related cognitive decline. It is widely available, acceptable to older people, and carries minimal risk of side effects or adverse events. Exercise - specifically, intense, multi-component exercise - also appears to affect brain structure and function and improve cognitive performance.
The investigators will randomize 580 non-demented healthy adults aged 65 to 84 to one of four conditions: MBSR alone, exercise alone, MBSR + exercise, or a health education discussion group control condition.
The study will consist of a 6-month acute intervention phase with weekly visits followed by a 12-month maintenance phase with weekly or monthly visits and other prompts to maintain intervention behaviors.
Assessments include cognitive tests, biomarkers, neuroimaging assessments, functional assessments to examine real-world benefits of the interventions, and other behavioral assessments to characterize participants and pave the way for further exploratory analyses.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBSR | Experimental | Mindfulness-Based Stress Reduction consists of a brief introductory meeting, eight weekly 2.5-hour classes, and a retreat, followed by monthly booster sessions for approximately 15 months. Content includes instruction in mindfulness meditation practices, gentle mindful movement, and exercises to enhance mindfulness in everyday life. |
|
| Exercise | Experimental | The exercise protocol is optimal for improving aerobic fitness and insulin sensitivity in older adults, as well as improving strength and balance and reducing indices of frailty.It consists of classes twice weekly for 6 months, building up to 1.5 hr, under the direct supervision of trained exercise instructors, followed by once weekly classes for 12 months. |
|
| MBSR + Exercise | Experimental | This condition will receive both MBSR and exercise as described above. Participants in this condition will come in once weekly to receive MBSR and twice weekly to receive exercise classes, with at-home exercise the other two days as well as daily, at-home mindfulness practice. After the initial classes participants will also attend additional weekly or monthly sessions until completion of the study. Note that at each site a pilot group is undergoing MBSR + Exercise (not randomized, separate from the RCT). |
|
| Health Education | Active Comparator | Health Education is a group-based intervention that increases health-related knowledge and action. Health Education improves chronic disease management.Health Education consists of ten weekly 2.5-hour classes, followed by monthly classes for approximately 15 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBSR | Behavioral |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Memory Composite Score | The memory composite variable consists of the list recall, paragraph recall, and picture sequence memory tasks. For each memory variable, a z score is computed for each participant [(participant score - mean)/standard deviation]. Then the composite memory variable is created by averaging the z scores. The higher the z-score, the better the outcome. A Z-score of 0 represents the population mean. | Month 0, Month 3, Month 6, and Month 18 |
| Cognitive Control Composite Score | The cognitive control composite variable uses the CVOE, SART, Color Word Interference, flanker, dimensional change card sort, and list-sorting tasks. For each cognitive variable, a z score is computed for each participant [(participant score - mean)/standard deviation]. Then the composite cognitive control variable is created by averaging the z scores. The higher the z-score, the better the outcome. A Z-score of 0 represents the population mean. | Month 0, Month 3, Month 6, Month 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Hippocampal Volume | The hippocampal volume is derived from structural MRI high-resolution T1-weighted images. | Month 0, Month 6, Month 18 |
| DLPFC Surface Area | The Dorsal Lateral Pre-Frontal Cortex (DLPFC) surface area is derived from structural MRI high-resolution T1-weighted images. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric J Lenze, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | San Diego | California | 92122 | United States | ||
| Washington University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36511926 | Derived | Lenze EJ, Voegtle M, Miller JP, Ances BM, Balota DA, Barch D, Depp CA, Diniz BS, Eyler LT, Foster ER, Gettinger TR, Head D, Hershey T, Klein S, Nichols JF, Nicol GE, Nishino T, Patterson BW, Rodebaugh TL, Schweiger J, Shimony JS, Sinacore DR, Snyder AZ, Tate S, Twamley EW, Wing D, Wu GF, Yang L, Yingling MD, Wetherell JL. Effects of Mindfulness Training and Exercise on Cognitive Function in Older Adults: A Randomized Clinical Trial. JAMA. 2022 Dec 13;328(22):2218-2229. doi: 10.1001/jama.2022.21680. |
| Label | URL |
|---|---|
| Visit the Healthy Mind Lab for more information about the MEDEX study and our other areas of research. STL: http://healthymind.wustl.edu/medex UCSD: http://www.medexstudy.com/ | View source |
Not provided
A cleaned, complete, and de-identified copy of the final data set including administrative and technical metadata records will be made available for release upon request to qualified investigators.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MBSR | Mindfulness-Based Stress Reduction consists of a brief introductory meeting, eight weekly 2.5-hour classes, and a retreat, followed by monthly booster sessions for approximately 15 months. Content includes instruction in mindfulness meditation practices, gentle mindful movement, and exercises to enhance mindfulness in everyday life. MBSR |
| FG001 | Exercise | The exercise protocol is optimal for improving aerobic fitness and insulin sensitivity in older adults, as well as improving strength and balance and reducing indices of frailty.It consists of classes twice weekly for 6 months, building up to 1.5 hr, under the direct supervision of trained exercise instructors, followed by once weekly classes for 12 months. Exercise |
| FG002 | MBSR + Exercise | This condition will receive both MBSR and exercise as described above. Participants in this condition will come in once weekly to receive MBSR and twice weekly to receive exercise classes, with at-home exercise the other two days as well as daily, at-home mindfulness practice. After the initial classes participants will also attend additional weekly or monthly sessions until completion of the study. Note that at each site a pilot group is undergoing MBSR + Exercise (not randomized, separate from the RCT). MBSR Exercise |
| FG003 | Health Education | Health Education is a group-based intervention that increases health-related knowledge and action. Health Education improves chronic disease management.Health Education consists of ten weekly 2.5-hour classes, followed by monthly classes for approximately 15 months. Health Education |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MBSR | Mindfulness-Based Stress Reduction consists of a brief introductory meeting, eight weekly 2.5-hour classes, and a retreat, followed by monthly booster sessions for approximately 15 months. Content includes instruction in mindfulness meditation practices, gentle mindful movement, and exercises to enhance mindfulness in everyday life. MBSR |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Memory Composite Score | The memory composite variable consists of the list recall, paragraph recall, and picture sequence memory tasks. For each memory variable, a z score is computed for each participant [(participant score - mean)/standard deviation]. Then the composite memory variable is created by averaging the z scores. The higher the z-score, the better the outcome. A Z-score of 0 represents the population mean. | modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention. | Posted | Least Squares Mean | Standard Error | Z-score | Month 0, Month 3, Month 6, and Month 18 |
|
The adverse events and serious adverse events were collected over a period of 18 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MBSR | Mindfulness-Based Stress Reduction consists of a brief introductory meeting, eight weekly 2.5-hour classes, and a retreat, followed by monthly booster sessions for approximately 15 months. Content includes instruction in mindfulness meditation practices, gentle mindful movement, and exercises to enhance mindfulness in everyday life. MBSR |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injury | General disorders | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Lenze | Washington University in St. Louis | 314-362-5154 | lenzee@wustl.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 10, 2018 | May 31, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 1, 2022 | May 31, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
Not provided
Not provided
| NIH |
| The Brain Research Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
|
| Exercise |
| Behavioral |
|
|
| Health Education | Behavioral |
|
| Month 0, Month 6, Month 18 |
| DLPFC Cortical Thickness | The Dorsal Lateral Pre-Frontal Cortex Cortical Thickness is derived from structural MRI high-resolution T1-weighted images. | Month 0, Month 6, and Month 18 |
| OTDL (Observed Tasks of Daily Living). | The Revised Observed Tasks of Daily Living (OTDL-R) is a performance-based test of everyday problem-solving. Subjects completed tasks testing medication use (following medicine label directions, and completing a patient record form); telephone use (finding and dialing a number from the yellow pages); and financial management (making change with coins and bills, and balancing a checkbook). The scores were summed with the total score having a range from 0 to 28. The higher the score, the more likely the participant is able to complete everyday activities. | Month 0, Month 6, Month 18 |
| Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). | The Quality of Life in Neurological Disorders (NQoL) Cognitive Function Scale is an 18-item self-report measure that assesses the health-related quality of life of adults. The total score ranges from 18 to 90 where a higher score represents a better outcome. | Month 0, Month 3, Month 6, Month 18 |
| St Louis |
| Missouri |
| 63110 |
| United States |
| BG001 |
| Exercise |
The exercise protocol is optimal for improving aerobic fitness and insulin sensitivity in older adults, as well as improving strength and balance and reducing indices of frailty.It consists of classes twice weekly for 6 months, building up to 1.5 hr, under the direct supervision of trained exercise instructors, followed by once weekly classes for 12 months. Exercise |
| BG002 | MBSR + Exercise | This condition will receive both MBSR and exercise as described above. Participants in this condition will come in once weekly to receive MBSR and twice weekly to receive exercise classes, with at-home exercise the other two days as well as daily, at-home mindfulness practice. After the initial classes participants will also attend additional weekly or monthly sessions until completion of the study. Note that at each site a pilot group is undergoing MBSR + Exercise (not randomized, separate from the RCT). MBSR Exercise |
| BG003 | Health Education | Health Education is a group-based intervention that increases health-related knowledge and action. Health Education improves chronic disease management.Health Education consists of ten weekly 2.5-hour classes, followed by monthly classes for approximately 15 months. Health Education |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Current smoker | Count of Participants | Participants |
|
| Years of education | Mean | Standard Deviation | years |
|
| APOE 4 positive | ApoE is a gene which can dramatically increase your risk for Alzheimer's. Patients who test positive for the apolipoprotein E4 (ApoE4) gene demonstrate an increased chance of Alzheimer's disease. | Count of Participants | Participants |
|
| CIRS-G | The Cumulative Illness Rating Scale for Geriatrics (CIRS-G) is a 14-item scale that assesses overall health. A total score is reported with a range of 0 to 56, where a higher score represents worse overall health. | Mean | Standard Deviation | units on a scale |
|
| CEI | The Credibility and Expectations Questionnaire (CEI) assessed subjective beliefs that the intervention is credible (will work). Participants also indicated their expectations that the assigned intervention would improve their condition (i.e. cognition). This questionnaire was given only after the first class. The credibility portion of the questionnaire consisted of four items (total score from 0 to 40), with a higher score representing more credibility. The expectation portion of the questionnaire consisted of one item, a percentage from 0% to 100% (higher: expect greater improvement). | Mean | Standard Deviation | units on a scale |
|
| Body Mass Index (BMI) Class | Body mass index or BMI is a statistical index using a person's weight and height to get an estimate of body fat in persons of any age. | Count of Participants | Participants |
|
| WTAR | The Wechsler Test of Adult Reading (WTAR) instrument is used to gain an estimate of IQ. Participants read 50 words from a page and were scored on correct pronunciation. Those with a standard score less than 70 were not eligible to participate in the study. The minimum raw score is 0 and the maximum raw score is 50. The standard score ranges from 52 to 128. The higher the score, the higher the estimated IQ. | Mean | Standard Deviation | units on a scale |
|
| SPPB modified score | The Short Physical Performance Battery (SPPB) measures gait speed, chair stand and balance. It is used as a tool for detecting disability and can help monitor the function in older adults. A total score was computed by summing the scores of gait speed, chair stand, and balance. The total score has a range from 1 to 12 where a higher score indicates higher functioning. All balance testing was measured using BtrackS balance tracking system, a computerized force platform provided a more objective and detailed assessment of balance than observation alone. | Mean | Standard Deviation | units on a scale |
|
| Paragraph recall | The Paragraph Recall task involves having the participant listen to two stories and then asking the participant to remember as many of the paragraph elements as possible. Each story has 44 elements. Therefore, the range is 0 to 88 for both the immediate recall task and the delayed recall task. The task is used to quantify memory performance. The greater the score, the higher the memory performance. | Mean | Standard Deviation | units on a scale |
|
| Word list | The Word List Learning and Recall tasks involve the participant recalling as many words as possible from a list containing 16 words. For the Learning task, the participant will try to recall as many words as possible for 4 trials. Therefore, the total score ranges from 0 to 64. The Recall task occurs 20 minutes following the Learning task, and again has the participant recall as many words as possible from the list. It has a range of 0 to 16. In both the Learning and Recall tasks, the higher the score, the better the outcome. | Mean | Standard Deviation | units on a scale |
|
| Neuro-QoL cognitive function score | The Quality of Life in Neurological Disorders (NQoL) Cognitive Function Scale is an 18-item self-report measure that assesses the health-related quality of life of adults. The total score ranges from 18 to 90 where a higher score represents a better outcome. | Mean | Standard Deviation | units on a scale |
|
| OTDL-R | The Revised Observed Tasks of Daily Living (OTDL-R) is a performance-based test of everyday problem-solving. Subjects completed tasks testing medication use (following medicine label directions, and completing a patient record form); telephone use (finding and dialing a number from the yellow pages); and financial management (making change with coins and bills, and balancing a checkbook). The scores were summed with the total score having a range from 0 to 28. The higher the score, the more likely the participant is able to complete everyday activities. | Mean | Standard Deviation | units on a scale |
|
| CAMS-R | The Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) is a brief 12-item self-report measure of mindfulness with items written in everyday language. Scores on the scale are summed with a range of 0 to 48. Higher values reflect greater mindful qualities. | Mean | Standard Deviation | units on a scale |
|
| NIH Toolbox Fluid Cognition Composite Score | This score was derived from averaging the standard scores of the Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting and Pattern Comparison tasks, and then deriving standard scores based on this new distribution. An uncorrected standard score at or near 100 indicates ability that is average compared with others nationally. A standard score of around 85 suggests significantly below-average fluid cognitive ability. The population mean is 100 with a standard deviation of 15. This scale does not have a full scale range. | Mean | Standard Deviation | units on a scale |
|
| Cortisol AUC | Mean | Standard Deviation | mcg*min/mL |
|
| Insulin sensitivity | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) measures how insulin resistant (IR) an individual is with a higher HOMA-IR indicating greater IR. HOMA-IR is computed using the fasting glucose and insulin values of an OGTT. The Oral Glucose Insulin Sensitivity (OGIS) index assesses insulin sensitivity using the insulin and glucose values obtained at the 0, 90, and 120-time points from a 2-hr OGTT. The higher the OGIS index, the more insulin sensitive an individual is. An OGIS of 302 (+/- 17) suggests impaired glucose tolerance. A HOMA-IR less than 1.0 indicates insulin sensitivity. | Mean | Standard Deviation | units on a scale |
|
| MBSR Negative |
This group consists of participants that did not receive the MBSR intervention. |
| OG002 | Exercise Positive | This group consists of participants that received the Exercise intervention. |
| OG003 | Exercise Negative | This group consists of participants that did not receive the Exercise intervention. |
|
|
|
| Primary | Cognitive Control Composite Score | The cognitive control composite variable uses the CVOE, SART, Color Word Interference, flanker, dimensional change card sort, and list-sorting tasks. For each cognitive variable, a z score is computed for each participant [(participant score - mean)/standard deviation]. Then the composite cognitive control variable is created by averaging the z scores. The higher the z-score, the better the outcome. A Z-score of 0 represents the population mean. | modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention. | Posted | Least Squares Mean | Standard Error | score on a scale | Month 0, Month 3, Month 6, Month 18 |
|
|
|
|
| Secondary | Hippocampal Volume | The hippocampal volume is derived from structural MRI high-resolution T1-weighted images. | modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention. | Posted | Least Squares Mean | Standard Error | millimeters^3 | Month 0, Month 6, Month 18 |
|
|
|
|
| Secondary | DLPFC Surface Area | The Dorsal Lateral Pre-Frontal Cortex (DLPFC) surface area is derived from structural MRI high-resolution T1-weighted images. | modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention. | Posted | Least Squares Mean | Standard Error | millimeters^2 | Month 0, Month 6, Month 18 |
|
|
|
|
| Secondary | DLPFC Cortical Thickness | The Dorsal Lateral Pre-Frontal Cortex Cortical Thickness is derived from structural MRI high-resolution T1-weighted images. | modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention. | Posted | Least Squares Mean | Standard Error | millimeters | Month 0, Month 6, and Month 18 |
|
|
|
|
| Secondary | OTDL (Observed Tasks of Daily Living). | The Revised Observed Tasks of Daily Living (OTDL-R) is a performance-based test of everyday problem-solving. Subjects completed tasks testing medication use (following medicine label directions, and completing a patient record form); telephone use (finding and dialing a number from the yellow pages); and financial management (making change with coins and bills, and balancing a checkbook). The scores were summed with the total score having a range from 0 to 28. The higher the score, the more likely the participant is able to complete everyday activities. | modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention. | Posted | Least Squares Mean | Standard Error | score on a scale | Month 0, Month 6, Month 18 |
|
|
|
|
| Secondary | Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). | The Quality of Life in Neurological Disorders (NQoL) Cognitive Function Scale is an 18-item self-report measure that assesses the health-related quality of life of adults. The total score ranges from 18 to 90 where a higher score represents a better outcome. | modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention. | Posted | Least Squares Mean | Standard Error | score on a scale | Month 0, Month 3, Month 6, Month 18 |
|
|
|
|
| 1 |
| 150 |
| 18 |
| 150 |
| 0 |
| 150 |
| EG001 | Exercise | The exercise protocol is optimal for improving aerobic fitness and insulin sensitivity in older adults, as well as improving strength and balance and reducing indices of frailty.It consists of classes twice weekly for 6 months, building up to 1.5 hr, under the direct supervision of trained exercise instructors, followed by once weekly classes for 12 months. Exercise | 0 | 138 | 16 | 138 | 0 | 138 |
| EG002 | MBSR + Exercise | This condition will receive both MBSR and exercise as described above. Participants in this condition will come in once weekly to receive MBSR and twice weekly to receive exercise classes, with at-home exercise the other two days as well as daily, at-home mindfulness practice. After the initial classes participants will also attend additional weekly or monthly sessions until completion of the study. Note that at each site a pilot group is undergoing MBSR + Exercise (not randomized, separate from the RCT). MBSR Exercise | 0 | 144 | 14 | 144 | 0 | 144 |
| EG003 | Health Education | Health Education is a group-based intervention that increases health-related knowledge and action. Health Education improves chronic disease management.Health Education consists of ten weekly 2.5-hour classes, followed by monthly classes for approximately 15 months. Health Education | 0 | 153 | 5 | 153 | 0 | 153 |
| Cardiovascular Event | General disorders | Non-systematic Assessment |
|
| Tumor/Cancer | General disorders | Non-systematic Assessment |
|
| Bowel Obstruction | General disorders | Non-systematic Assessment |
|
| Asthma (Syncope) | General disorders | Non-systematic Assessment |
|
| Pneumonia | General disorders | Non-systematic Assessment |
|
| Blood Infection | General disorders | Non-systematic Assessment |
|
| Ocular Migraine with Aphasia | General disorders | Non-systematic Assessment |
|
| Viral Infection | General disorders | Non-systematic Assessment |
|
| Shingles/Urinary Tract Infection | General disorders | Non-systematic Assessment |
|
| Leg Infection | General disorders | Non-systematic Assessment |
|
| Pulmonary Embolism | General disorders | Non-systematic Assessment |
|
| Kidney Stone | General disorders | Non-systematic Assessment |
|
| Inflammatory Myopathy | General disorders | Non-systematic Assessment |
|
| Neck Pain | General disorders | Non-systematic Assessment |
|
| Transient Ischemic Attack (TIA) | General disorders | Non-systematic Assessment |
|
| Laminectomy | General disorders | Non-systematic Assessment |
|
| Bronchitis | General disorders | Non-systematic Assessment |
|
| Knee Replacement Surgery | General disorders | Non-systematic Assessment |
|
| Pancreatitis | General disorders | Non-systematic Assessment |
|
| Hip Replacement Surgery | General disorders | Non-systematic Assessment |
|
| Diverticulitis | General disorders | Non-systematic Assessment |
|
| Enlarged Prostate | General disorders | Non-systematic Assessment |
|
| Kidney Failure | General disorders | Non-systematic Assessment |
|
| High Blood Pressure | General disorders | Non-systematic Assessment |
|
| Death | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D004191 |
| Behavioral Disciplines and Activities |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| Month 3 |
|
| Month 6 |
|
| Month 18 |
|
| 0.44 |
| Mean Difference (Final Values) |
| -0.04 |
| 2-Sided |
| 95 |
| -0.15 |
| 0.07 |
| Superiority |
| Time x Exercise (Month 0 and Month 6) | Marginal Model | 0.17 | Mean Difference (Final Values) | 0.07 | 2-Sided | 95 | -0.03 | 0.18 | Superiority |
| Time x Exercise (Month 0 and Month 18). | Marginal Model | 0.93 | Mean Difference (Final Values) | -0.01 | 2-Sided | 95 | -0.12 | 0.11 | Superiority |
| Month 6 |
|
| Month 18 |
|
| 0.004 |
| Mean Difference (Final Values) |
| -20.16 |
| 2-Sided |
| 95 |
| -33.88 |
| -6.44 |
| Superiority |
| Time x Exercise (Month 0 and Month 6) | Marginal Model | 0.58 | Mean Difference (Final Values) | 3.04 | 2-Sided | 95 | -7.76 | 13.85 | Superiority |
| Time x Exercise (Month 0 and Month 18). | Marginal Model | 0.37 | Mean Difference (Final Values) | -6.26 | 2-Sided | 95 | -19.98 | 7.46 | Superiority |
| Month 6 |
|
| Month 18 |
|
| 0.31 |
| Mean Difference (Final Values) |
| 25.35 |
| 2-Sided |
| 95 |
| -23.18 |
| 73.88 |
| Superiority |
| Time x Exercise (Month 0 and Month 6). | Marginal Model | 0.46 | Mean Difference (Final Values) | -17.18 | 2-Sided | 95 | -62.83 | 28.48 | Superiority |
| Time x Exercise (Month 0 and Month 18). | Marginal Model | 0.39 | Mean Difference (Final Values) | 21.11 | 2-Sided | 95 | -27.41 | 69.64 | Superiority |
| Month 6 |
|
| Month 18 |
|
| 0.10 |
| Mean Difference (Final Values) |
| -0.01 |
| 2-Sided |
| 95 |
| -0.02 |
| 0.00 |
| Superiority |
| Time x Exercise (Month 0 and Month 6). | Marginal Model | 0.21 | Mean Difference (Final Values) | 0.01 | 2-Sided | 95 | -0.004 | 0.02 | Superiority |
| Time x Exercise (Month 0 and Month 18). | Marginal Model | 0.09 | Mean Difference (Final Values) | -0.01 | 2-Sided | 95 | -0.02 | 0.00 | Superiority |
| Month 6 |
|
| Month 18 |
|
| 0.96 |
| Mean Difference (Final Values) |
| -0.01 |
| 2-Sided |
| 95 |
| -0.58 |
| 0.55 |
| Superiority |
| Time x Exercise (Month 0 and Month 6). | Marginal Model | 0.37 | Mean Difference (Final Values) | -0.24 | 2-Sided | 95 | -0.78 | 0.29 | Superiority |
| Time x Exercise (Month 0 and Month 18). | Marginal Model | 0.99 | Mean Difference (Final Values) | -0.003 | 2-Sided | 95 | -0.57 | 0.57 | Superiority |
| Month 3 |
|
| Month 6 |
|
| Month 18 |
|
| 0.09 |
| Mean Difference (Final Values) |
| 1.29 |
| 2-Sided |
| 95 |
| -0.19 |
| 2.77 |
| Superiority |
| Time x Exercise (Month 0 and Month 6). | Marginal Model | 0.42 | Mean Difference (Final Values) | -0.57 | 2-Sided | 95 | -1.97 | 0.83 | Superiority |
| Time x Exercise (Month 0 and Month 18). | Marginal Model | 0.54 | Mean Difference (Final Values) | 0.47 | 2-Sided | 95 | -1.01 | 1.94 | Superiority |