Alzheimer DiseaseEFA-PNCT02195596
Effects of Exercise on Cognitive Performance of Patients With Alzheimer-type Dementia. Pilot Study.
A study testing High intensity aerobic exercise+strength and Low intensity aerobic exercise+strength in people with Alzheimer Disease, run by Basque Health Service at 3 sites in Spain.
Trial summary
A program that combines high intensity aerobic exercise (<85% of Heart Rate Reserve) with resistance, progressive and moderate intensity intervals, carried out in primary care, is effective in terms of a smaller increase in respect to the baseline measurement in the total score of the ADAS cognitive section (Alzheimer… Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- High intensity aerobic exercise+strength and Low intensity aerobic exercise+strength
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesSpain
- Study dates
- Apr 2013to Dec 2015
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Subjects aged between 55 and 85 who meet, at the time of entry into the study, clinical criteria compatible with probable AD according to the criteria of the National Institute on Aging and the Alzheimer's Association, under mild or DCL-Alzheimers (Folstein MMSE> 19/20, GDS 3-4), diagnosis will be performed by specialist neurologists according to standard practice. Patients should be able to perform physical activity on a cycle ergometer or treadmill and also must exist a caregiver who agrees to accompany him to the physical exercise sessions.
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Exclusion Criteria: Central nervous system disease history with the possibility of neuropsychological impairment (stroke, epilepsy, meningitis, severe head trauma). History of alcohol and drug abuse. Hachinski Ischemic Scale ≥ 7. Major depression diagnosed(CIE-10). History of severe psychiatric disease. Predictable changes in medication that may affect cognitive performance. Visual or auditory perceptual disorders that limit neuropsychological assessment. Unstable heart disease, severe behavioral problems that make impossible the intervention, or any condition judged by the investigator that advises against the intervention. -
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
Basauri C.S.
Basauri, Bizkaia
NEREA FONCEA BETI, PHD, 03494 4007234, NEREA.FONCEABETI@osakidetza.net
VERÓNICA ARCE ARANA
- Not yet recruiting
Hospital Universitario de Basurto
Bilbao, Bizkaia
JUAN Mª UTERGA VALIENTE, PHD, 944006074, JUANMARIA.UTERGAVALIENTE@osakidetza.net
MAITE ESPINOSA CIFUENTES, MD
- Recruiting
Galdakao Hospital/Galdakao C.S.
Galdakao, Bilbao
Mª ANGELES GOMEZ BELDARRAIN, PHD, 34 94 400 7234, MARIAANGELES.GOMEZBELDARRAIN@osakidetza.net
JAVIER RUIZ OJEDA, PHD, 34 94 400 7234, JAVIER.RUIZOJEDA@OSAKIDETZA.NET
About this study
A program that combines high intensity aerobic exercise (<85% of Heart Rate Reserve) with resistance, progressive and moderate intensity intervals, carried out in primary care, is effective in terms of a smaller increase in respect to the baseline measurement in the total score of the ADAS cognitive section (Alzheimer Disease Assessment Scale-Cognitive section),in the control group that receives an intervention similar to low intensity (30-40% of Heart rate reserve).
We Expect a difference of at least 3 points between the means of the increments between the intervention and control group.
Read the detailed description
OBJECTIVE: To evaluate an intervention that combines high intensity aerobic exercise with strength (AAAD) on general cognitive performance of patients affected by mild Alzheimer's disease (AD). DESIGN: Randomized clinical trial in two parallel groups: SCOPE: 2 health center of Basque Health Service , in coordination with its reference neurology services. PARTICIPANTS: 80 patients with mild AD.
INTERVENTION: Both groups receiving standard drug treatment. The intervention group also receive a supervised EEAA program, while the control group receive a similar intervention at low intensity. Patients are followed up over 1 year. Three blind measurements are made repeatedly : baseline, at 6 and 12 months. MEASUREMENTS: The primary outcome measure is change in cognitive performance that is measured in a blinded way with the cognitive section of the ADAS scale (Alzheimer's Disease Assessment Scale) at 0, 6 and 12.Secondary Outcomes: Global cognitive performance (Neuropsychological battery TBR-B),neuropsychiatric symptoms (NPI), ADL (Blessed),functional capacity (Test of 6-minute walk), cardiorespiratory Test, muscular strength (hand dynamometer and trunk); PREDICTORS AND CONFOUNDING VARIABLES: baseline cognitive performance, previous physical activity, medication, age, sex, APOE, schooling and cognitive reserve. ANALYSIS: We compared the two groups in terms of observed mean changes from baseline in ADAS measurement and other variables, intention to treat, using longitudinal mixed effects models for repeated measures at 6 and 12 months.
- Conditions
- Alzheimer Disease
- Being tested
- High intensity aerobic exercise+strength, Low intensity aerobic exercise+strength
- Keywords
- Alzheimer disease, exercise, cognition
- 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.
High intensity aerobic exercise+strengthOther
The program consist in a "Continuous High aerobic exercise and moderate intensity intervals" (ShoshanaB et al, 2012) combined with "muscular strength exercises and joint mobility". Patients come three times a week for six months to the primary health center and will be supervised by an expert nurse.
Low intensity aerobic exercise+strengthOther
Low intensity aerobic exercise+strength program is similar to the other intervention but differs in the intensity of the exercise as it works with intensities below 40% of heart rate reserve.
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| Study group | Role | What they receive |
|---|---|---|
| High intensity aerobic exercise+strength | Experimental | The program consist in a "Continuous High aerobic exercise and moderate intensity intervals" (ShoshanaB et al, 2012) combined with "muscular strength exercises and joint mobility". Patients come three times a week for six months to the primary health center. A fitness expert nurse is responsible for monitoring the performance and adapt to the physical condition of the patient.Each exercise session consists of warming up time period, period of work and back to calm. Exercise intensity during the work period increases progressively as the program progresses. Aerobic exercise is performed on a cycle ergometer or treadmill.Muscle strength exercises and joint mobility are performed with dumbbells and ankle weights adapted to each patient. Receives: Other: High intensity aerobic exercise+strength |
| Low intensity aerobic exercise+strength | Active comparator | The control group performed an exercise program similar to intervention but at low intensity that is below 35 or 40% of heart rate reserve (HRR). Receives: Other: Low intensity aerobic exercise+strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive performance that is measured in a blinded way with the cognitive section of the ADAS scale (Alzheimer's Disease Assessment Scale) at 0, 6 and 12
Cognitive performance is measured in a blinded way with the cognitive section of the ADAS scale (Alzheimer's Disease Assessment Scale) at 0, 6 and 12. ADAS is an instrument designed to assess the severity of cognitive disorders (ADAS-Cog) and noncognitive (ADAS-cog) in patients with Alzheimer-type dementia (ATD). The ADAS-Cog, that we use, consists of 11 items that assess mainly memory (3 items, 27 points), orientation (1 item, 8 points), language (5 items, 25 points) and praxis (2 items, 10 points). The maximum score is 70 points.The higher the score, the greater the cognitive impairment.This is the primary outcome measure most frequently used in clinical trials with drugs.
Measured: 0, 6 and 12 months
Secondary outcomes (1)
Global cognitive performance
Global cognitive performance is measured with Test Barcelona TBR-B neuropsychological battery (abreviated version).The ADAS-COG wich is focused on the most devastated areas by Alzheimer's disease, will be complemented by the TBA-B, which has been developed in our environment, makes possible a more global assessment, and also presents adequate psychometric properties.
Measured: 0, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startApr 2013
- Primary completionJan 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ana Dosío Revenga, Basque Health Service
- Investigators
- ANA DOSIO REVENGA, PHD, Principal investigator, Osakidetza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195596
- Sponsor's protocol ID
- 2011111100
- Acronym
- EFA-P
- Status last verified
- Jul 2014
- First submitted
- 18 Jul 2014
- Last updated
- 21 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise on Cognitive Performance of Patients With Alzheimer-type Dementia. Pilot Study.
- ClinicalTrials.gov ID
- NCT02195596
- Acronym / sponsor ID
- EFA-P / 2011111100
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer disease, exercise, cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- Apr 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 21 Jul 2014 (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.
A program that combines high intensity aerobic exercise (<85% of Heart Rate Reserve) with resistance, progressive and moderate intensity intervals, carried out in primary care, is effective in terms of a smaller increase in respect to the baseline measurement in the total score of the ADAS cognitive section (Alzheimer Disease Assessment Scale-Cognitive section),in the control group that receives an intervention similar to low intensity (30-40% of Heart rate reserve).
We Expect a difference of at least 3 points between the means of the increments between the intervention and control group.
Detailed description
OBJECTIVE: To evaluate an intervention that combines high intensity aerobic exercise with strength (AAAD) on general cognitive performance of patients affected by mild Alzheimer's disease (AD). DESIGN: Randomized clinical trial in two parallel groups: SCOPE: 2 health center of Basque Health Service , in coordination with its reference neurology services. PARTICIPANTS: 80 patients with mild AD.
INTERVENTION: Both groups receiving standard drug treatment. The intervention group also receive a supervised EEAA program, while the control group receive a similar intervention at low intensity. Patients are followed up over 1 year. Three blind measurements are made repeatedly : baseline, at 6 and 12 months. MEASUREMENTS: The primary outcome measure is change in cognitive performance that is measured in a blinded way with the cognitive section of the ADAS scale (Alzheimer's Disease Assessment Scale) at 0, 6 and 12.Secondary Outcomes: Global cognitive performance (Neuropsychological battery TBR-B),neuropsychiatric symptoms (NPI), ADL (Blessed),functional capacity (Test of 6-minute walk), cardiorespiratory Test, muscular strength (hand dynamometer and trunk); PREDICTORS AND CONFOUNDING VARIABLES: baseline cognitive performance, previous physical activity, medication, age, sex, APOE, schooling and cognitive reserve. ANALYSIS: We compared the two groups in terms of observed mean changes from baseline in ADAS measurement and other variables, intention to treat, using longitudinal mixed effects models for repeated measures at 6 and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity aerobic exercise+strength | Experimental | Other: High intensity aerobic exercise+strengthThe program consist in a "Continuous High aerobic exercise and moderate intensity intervals" (ShoshanaB et al, 2012) combined with "muscular strength exercises and joint mobility". Patients come three times a week for six months to the primary health center. A fitness expert nurse is responsible for monitoring the performance and adapt to the physical condition of the patient.Each exercise session consists of warming up time period, period of work and back to calm. Exercise intensity during the work period increases progressively as the program progresses. Aerobic exercise is performed on a cycle ergometer or treadmill.Muscle strength exercises and joint mobility are performed with dumbbells and ankle weights adapted to each patient. |
| Low intensity aerobic exercise+strength | Active comparator | Other: Low intensity aerobic exercise+strengthThe control group performed an exercise program similar to intervention but at low intensity that is below 35 or 40% of heart rate reserve (HRR). |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| High intensity aerobic exercise+strengthThe program consist in a "Continuous High aerobic exercise and moderate intensity intervals" (ShoshanaB et al, 2012) combined with "muscular strength exercises and joint mobility". Patients come three times a week for six months to the primary health center and will be supervised by an expert nurse. | Other | High intensity aerobic exercise+strength |
| Low intensity aerobic exercise+strengthLow intensity aerobic exercise+strength program is similar to the other intervention but differs in the intensity of the exercise as it works with intensities below 40% of heart rate reserve. -------------------------------------------------------------------------------- | Other | Low intensity aerobic exercise+strength |
Primary outcome
Change in cognitive performance that is measured in a blinded way with the cognitive section of the ADAS scale (Alzheimer's Disease Assessment Scale) at 0, 6 and 12
Time frame: 0, 6 and 12 months
Cognitive performance is measured in a blinded way with the cognitive section of the ADAS scale (Alzheimer's Disease Assessment Scale) at 0, 6 and 12. ADAS is an instrument designed to assess the severity of cognitive disorders (ADAS-Cog) and noncognitive (ADAS-cog) in patients with Alzheimer-type dementia (ATD). The ADAS-Cog, that we use, consists of 11 items that assess mainly memory (3 items, 27 points), orientation (1 item, 8 points), language (5 items, 25 points) and praxis (2 items, 10 points). The maximum score is 70 points.The higher the score, the greater the cognitive impairment.This is the primary outcome measure most frequently used in clinical trials with drugs.
1 secondary outcome
Global cognitive performance
Time frame: 0, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
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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.
ANA DOSIO REVENGA, PHD principal investigator
Osakidetza
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity aerobic exercise+strength and Low intensity aerobic exercise+strength in people with Alzheimer Disease, run by Basque Health Service at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GONZALO GRANDES ODRIOZOLA, PHD (0034946006637, gonzalo.grandesodriozola@osakidetza.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive performance that is measured in a blinded way with the cognitive section of the ADAS scale (Alzheimer's Disease Assessment Scale) at 0, 6 and 12 (time frame: 0, 6 and 12 months). 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 21 Jul 2014.