Alzheimer's DiseaseEXTRANCT01311492
Exercise Trial for Alzheimer's Disease
A study testing Healthy Lifestyle Program and Physical Activity Intervention in people with Alzheimer's Disease, run by Pennington Biomedical Research Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Healthy Lifestyle Program and Physical Activity Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to Apr 2013
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years and older
- must be planning to reside in the area for 1 year
- summary scor of greater than or equal to 3 on the Short Physical Performance Battery (SPPB)
- have mild to moderate AD defined by a score of 12-24 on the Mini-Mental Status Examination (MMSE). Diagnosis of probable AD from site physician utilizing the following criteria: Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for Dementia of Alzheimer's Type, National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) Criteria for Probable Alzheimer's Disease, and Hachinski Ischemic Score is less than or equal to 4
- sedentary lifestyle which is operationally defined as spending less than 20 minutes a week in the past month getting regular physical activity.
- must be willing to give informed consent, be willing to be randomized to either physical activity or health lifestyle intervention, and to follow the protocol for the group to which they have been assigned
Who cannot join
- unable or unwilling to give informed consent or accept randomization in either study group
- current diagnosis of schizophreniz, other psychotic disorders, or bipolar disorder
- current consumption of more than 14 alcoholic drinks per week
- plans to relocate to out of the study area within the next year or plans to be out of the study area for more than 6 weeks in the next year
- score of greater than 3 on SPPB
- another member of the household is a participant in they study
Show all 11Show fewer
- residence too far from the intervention site
- difficulty in communication with study personnel due to speech or hearing problems
- MMSE less than 12 or greater than 24
- currently enrolled in another randomized trial involving lifestyle or phamaceutical interventions
- other medical, psychiatric, or behavioral factors that in the judgement of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Programs of All-Inclusive Care for the Elderly (PACE)
Baton Rouge, Louisiana, 70806
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Exercise Trial for Alzheimer's Disease (EXTRA)
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.
Read the detailed description
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.
- Conditions
- Alzheimer's Disease
- Being tested
- Healthy Lifestyle Program, Physical Activity Intervention
- Keywords
- Alzheimer's Disease, exercise, physical activity, intervention
- Medical subject headings
- Alzheimer Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Lifestyle ProgramBehavioural
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.
Physical Activity InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Healthy Lifestyle Program |
| Physical Activity Intervention | Active comparator | The physical activity program includes aerobic, strenth, flexibility and balance training. Receives: Behavioral: Physical Activity Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
Evidence based feasibility for conducting exercise interventions in the Alzheimer's Disease population.
The third hypothesis is that well controlled exercise interventions can be successfully implemented in subjects with Alzheimer's Disease.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy S. Church, MD, MPH, PhD, Principal investigator, Pennington Biomedical Research CenterJeffrey N. Keller, PhD, Principal investigator, Pennington Biomedical Research CenterRobert M. Brouilette, MS, Study director, Pennington Biomedical Research CenterValerie H. Myers, PhD, Study director, Pennington Biomedical Research CenterSusan Nelson, MD, Study director, Programs of All-Inclusive Care for the Elderly (P.A.C.E.)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311492
- Sponsor's protocol ID
- PBRC 10035
- Acronym
- EXTRA
- Status last verified
- May 2013
- First submitted
- 7 Mar 2011
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
American College of Sports Medicine Position Stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 1998 Jun;30(6):992-1008.
PubMed 9624662Bassett 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.
PubMed 10993417Ettinger 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.
PubMed 8980206Ferrucci 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.
PubMed 10983911Fletcher 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.
PubMed 11581152Gordon 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.
PubMed 7572673Guralnik 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.
PubMed 10811152Guralnik 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.
PubMed 10496547Guralnik 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.
PubMed 7838189Guralnik 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.
PubMed 8126356Guralnik 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.
PubMed 7748914Hollenberg 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.
PubMed 18314555King 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.
PubMed 8980207King 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.
PubMed 9838975Marcus BH, Simkin LR. The transtheoretical model: applications to exercise behavior. Med Sci Sports Exerc. 1994 Nov;26(11):1400-4.
PubMed 7837962
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Trial for Alzheimer's Disease (EXTRA)
- ClinicalTrials.gov ID
- NCT01311492
- Acronym / sponsor ID
- EXTRA / PBRC 10035
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, exercise, physical activity, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Mar 2011 (estimated)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Lifestyle Program | Placebo comparator | Behavioral: Healthy Lifestyle ProgramThe 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 | Behavioral: Physical Activity InterventionThe physical activity program includes aerobic, strenth, flexibility and balance training. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 65 years and older
- must be planning to reside in the area for 1 year
- summary scor of greater than or equal to 3 on the Short Physical Performance Battery (SPPB)
- have mild to moderate AD defined by a score of 12-24 on the Mini-Mental Status Examination (MMSE). Diagnosis of probable AD from site physician utilizing the following criteria: Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for Dementia of Alzheimer's Type, National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) Criteria for Probable Alzheimer's Disease, and Hachinski Ischemic Score is less than or equal to 4
- sedentary lifestyle which is operationally defined as spending less than 20 minutes a week in the past month getting regular physical activity.
Key exclusion criteria (11 listed)
- unable or unwilling to give informed consent or accept randomization in either study group
- current diagnosis of schizophreniz, other psychotic disorders, or bipolar disorder
- current consumption of more than 14 alcoholic drinks per week
- plans to relocate to out of the study area within the next year or plans to be out of the study area for more than 6 weeks in the next year
- score of greater than 3 on SPPB
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 |
|---|---|---|
| Healthy Lifestyle ProgramThe 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. | Behavioural | Healthy Lifestyle Program |
| Physical Activity InterventionThe 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. | Behavioural | Physical Activity Intervention |
Primary outcome
Effect of exercise on cognitive decline
Time frame: 6 months
The primary hypothesis is that exercise will decrease the congnitive decline in activities of daily living, in the subjects with Alzheimer's Disease.
2 secondary outcomes
Measuring the effects of exercise on depression, metabolic indices, and changes in overall function.
Time frame: 6 months
Evidence based feasibility for conducting exercise interventions in the Alzheimer's Disease population.
Time frame: 6 months
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 15 Sep 2022.
- Background: PubMed 9624662American College of Sports Medicine Position Stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 1998 Jun;30(6):992-1008.
- Background: PubMed 10993417Bassett 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.
- Background: PubMed 8980206Ettinger 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.
- Background: PubMed 10983911Ferrucci 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.
- Background: PubMed 11581152Fletcher 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.
- Background: PubMed 7572673Gordon 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.
- Background: PubMed 10811152Guralnik 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.
- Background: PubMed 10496547Guralnik 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.
- Background: PubMed 7838189Guralnik 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.
- Background: PubMed 8126356Guralnik 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.
- Background: PubMed 7748914Guralnik 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.
- Background: PubMed 18314555Hollenberg 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.
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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.
Timothy S. Church, MD, MPH, PhD principal investigator
Pennington Biomedical Research Center
Jeffrey N. Keller, PhD principal investigator
Pennington Biomedical Research Center
Robert M. Brouilette, MS study director
Pennington Biomedical Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Lifestyle Program and Physical Activity Intervention in people with Alzheimer's Disease, run by Pennington Biomedical Research Center at 2 sites 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 6 inclusion and 11 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 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Effect of exercise on cognitive decline (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01311492, which also lists 19 linked publications.
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 15 Sep 2022.