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Exercise Trial for Alzheimer's Disease(EXTRA) is a pilot randomized clinical trial involving a physcial activity program versus a healthy lifestyle program, with one year follow-up in 30 non-disabled, community-dwelling persons, age 65 and older.
Alzheimer's disease (AD) occurs in 1 in 7 individuals over 65, and 1 in 2 individuals over 85. While the progression of AD is extremely variable, it is generally established that AD subjects will move from having compromised function in socail and work settings, to requiring institutionalization and/or intensive management within 10 years of initial clinical diagnosis. A randomized controlled piot trial is needed to provide information regarding exercies effects on individuals with mild to moderate Alzheimer's disease.
Exercise Trial for Alzheimer's Disease (EXTRA) is a pilot randomized controlled trial designed to compare a moderate-intesity physical activity program to a healthy lifestyle health education program in 30 older adults with mild to moderate Alzheimer's Disease. These individuals will be followed for 1 year.
This trial will provide pilot evidence regarding whether physical activity is effective and practical for individuals with AD. The effects of an exercise intervention on halting, slowing, or reversing the cognitive effects of AD will be assessed with pilot data and potentially provide support for a larger trial in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Lifestyle Program | Placebo Comparator | The purpose of the healthy lifestyle group is to control for general levels of staff and participant time and attention, in addition to general secular and seasonal effects that could influence the outcomes of interest. |
|
| Physical Activity Intervention | Active Comparator | The physical activity program includes aerobic, strenth, flexibility and balance training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Lifestyle Program | Behavioral | The healthy lifestyle program includes upper body stretching and educational workshops. The purpose of this group is to control for general levels of staff and participant time and attention, in addition to general secular and seasonal effects that could influence the outcomes of interest. The rational for this "placebo exercise" activity is that it helps foster adherence to this arm of the study and increases the perceived benefit of the healthy lifestyle program to the participants without directly affecting the study outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of exercise on cognitive decline | The primary hypothesis is that exercise will decrease the congnitive decline in activities of daily living, in the subjects with Alzheimer's Disease. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring the effects of exercise on depression, metabolic indices, and changes in overall function. | The secondary hypothesis is that exercise will decrease the level of depression, improve multiple metabolic indices, and improve function in subjects with Alzheimer's Disease. | 6 months |
| Evidence based feasibility for conducting exercise interventions in the Alzheimer's Disease population. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy S. Church, MD, MPH, PhD | Pennington Biomedical Research Center | Principal Investigator |
| Jeffrey N. Keller, PhD | Pennington Biomedical Research Center | Principal Investigator |
| Robert M. Brouilette, MS | Pennington Biomedical Research Center | Study Director |
| Valerie H. Myers, PhD | Pennington Biomedical Research Center | Study Director |
| Susan Nelson, MD | Programs of All-Inclusive Care for the Elderly (P.A.C.E.) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Programs of All-Inclusive Care for the Elderly (PACE) | Baton Rouge | Louisiana | 70806 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9624662 | Background | American College of Sports Medicine Position Stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 1998 Jun;30(6):992-1008. | |
| 10993417 | Background | Bassett DR Jr, Ainsworth BE, Swartz AM, Strath SJ, O'Brien WL, King GA. Validity of four motion sensors in measuring moderate intensity physical activity. Med Sci Sports Exerc. 2000 Sep;32(9 Suppl):S471-80. doi: 10.1097/00005768-200009001-00006. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Physical Activity Intervention | Behavioral | The physical activity intervention consists of a general weekly physical activity goal of 150 minutes. This is consistent with the public health message from the Surgeon General's report that moderate physical activity should be performed for 30 minutes on most if not all days of the week (150-210 total minutes). This goal is approached in a progressive manner over the course of the trial. |
|
The third hypothesis is that well controlled exercise interventions can be successfully implemented in subjects with Alzheimer's Disease. |
| 6 months |
| Pennington Biomedical Research Center |
| Baton Rouge |
| Louisiana |
| 70808 |
| United States |
| 8980206 | Background | Ettinger WH Jr, Burns R, Messier SP, Applegate W, Rejeski WJ, Morgan T, Shumaker S, Berry MJ, O'Toole M, Monu J, Craven T. A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis. The Fitness Arthritis and Seniors Trial (FAST). JAMA. 1997 Jan 1;277(1):25-31. |
| 10983911 | Background | Ferrucci L, Penninx BW, Leveille SG, Corti MC, Pahor M, Wallace R, Harris TB, Havlik RJ, Guralnik JM. Characteristics of nondisabled older persons who perform poorly in objective tests of lower extremity function. J Am Geriatr Soc. 2000 Sep;48(9):1102-10. doi: 10.1111/j.1532-5415.2000.tb04787.x. |
| 11581152 | Background | Fletcher GF, Balady GJ, Amsterdam EA, Chaitman B, Eckel R, Fleg J, Froelicher VF, Leon AS, Pina IL, Rodney R, Simons-Morton DA, Williams MA, Bazzarre T. Exercise standards for testing and training: a statement for healthcare professionals from the American Heart Association. Circulation. 2001 Oct 2;104(14):1694-740. doi: 10.1161/hc3901.095960. No abstract available. |
| 7572673 | Background | Gordon NF, Kohl HW 3rd, Pollock ML, Vaandrager H, Gibbons LW, Blair SN. Cardiovascular safety of maximal strength testing in healthy adults. Am J Cardiol. 1995 Oct 15;76(11):851-3. doi: 10.1016/s0002-9149(99)80245-8. No abstract available. |
| 10811152 | Background | Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221. |
| 10496547 | Background | Guralnik JM, Ferrucci L, Penninx BW, Kasper JD, Leveille SG, Bandeen-Roche K, Fried LP. New and worsening conditions and change in physical and cognitive performance during weekly evaluations over 6 months: the Women's Health and Aging Study. J Gerontol A Biol Sci Med Sci. 1999 Aug;54(8):M410-22. doi: 10.1093/gerona/54.8.m410. |
| 7838189 | Background | Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. N Engl J Med. 1995 Mar 2;332(9):556-61. doi: 10.1056/NEJM199503023320902. |
| 8126356 | Background | Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85. |
| 7748914 | Background | Guralnik JM, Seeman TE, Tinetti ME, Nevitt MC, Berkman LF. Validation and use of performance measures of functioning in a non-disabled older population: MacArthur studies of successful aging. Aging (Milano). 1994 Dec;6(6):410-9. doi: 10.1007/BF03324272. |
| 18314555 | Background | Hollenberg M, Ngo LH, Turner D, Tager IB. Treadmill exercise testing in an epidemiologic study of elderly subjects. J Gerontol A Biol Sci Med Sci. 1998 Jul;53(4):B259-67. doi: 10.1093/gerona/53a.4.b259. |
| 8980207 | Background | King AC, Oman RF, Brassington GS, Bliwise DL, Haskell WL. Moderate-intensity exercise and self-rated quality of sleep in older adults. A randomized controlled trial. JAMA. 1997 Jan 1;277(1):32-7. |
| 9838975 | Background | King AC, Rejeski WJ, Buchner DM. Physical activity interventions targeting older adults. A critical review and recommendations. Am J Prev Med. 1998 Nov;15(4):316-33. doi: 10.1016/s0749-3797(98)00085-3. |
| 7837962 | Background | Marcus BH, Simkin LR. The transtheoretical model: applications to exercise behavior. Med Sci Sports Exerc. 1994 Nov;26(11):1400-4. |
| 11078100 | Background | Penninx BW, Ferrucci L, Leveille SG, Rantanen T, Pahor M, Guralnik JM. Lower extremity performance in nondisabled older persons as a predictor of subsequent hospitalization. J Gerontol A Biol Sci Med Sci. 2000 Nov;55(11):M691-7. doi: 10.1093/gerona/55.11.m691. |
| 9989320 | Background | Rejeski WJ, Martin KA, Miller ME, Ettinger WH Jr, Rapp S. Perceived importance and satisfaction with physical function in patients with knee osteoarthritis. Ann Behav Med. 1998 Spring;20(2):141-8. doi: 10.1007/BF02884460. |
| 10993418 | Background | Welk GJ, Differding JA, Thompson RW, Blair SN, Dziura J, Hart P. The utility of the Digi-walker step counter to assess daily physical activity patterns. Med Sci Sports Exerc. 2000 Sep;32(9 Suppl):S481-8. doi: 10.1097/00005768-200009001-00007. |
| 20363136 | Background | Hollman JH, Childs KB, McNeil ML, Mueller AC, Quilter CM, Youdas JW. Number of strides required for reliable measurements of pace, rhythm and variability parameters of gait during normal and dual task walking in older individuals. Gait Posture. 2010 May;32(1):23-8. doi: 10.1016/j.gaitpost.2010.02.017. Epub 2010 Apr 2. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |