Alzheimer DiseaseExCiTE-ANCT03981159
Effect of Exercise Training in Alzheimer's Patients
A study testing Physical training in people with Alzheimer Disease, run by University of Genova at 1 site in Italy.
Trial summary
The objective of this study was to examine the effects of exercise training on physical function and biochemical markers in elderly Alzheimer's disease patients. Read more about this study
- Who is it for?
- Ages 80 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Physical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2017to 15 Nov 2017
- 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 80 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects with official diagnosis of Alzheimer's disease;
- Subjects with MMSE higher than12.
Who cannot join
- Subjects with MMSE below 12 (indicating severe dementia and impairment).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Exercise Training on Biochemical and Gait/Balance Parameters in Alzheimer's Patients
The objective of this study was to examine the effects of exercise training on physical function and biochemical markers in elderly Alzheimer's disease patients.
Read the detailed description
Alzheimer's disease is a neurodegenerative disease characterized by progressive and irreversible degeneration of nerve cells. The loss of these cells leads to the continuous decline in muscle function with alterations in biochemical and haematological parameters. The objective of this study was to examine the effects of exercise training on physical function and biochemical markers in elderly Alzheimer's disease patients.
- Conditions
- Alzheimer Disease
- Being tested
- Physical training
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical trainingOther
Physical training for three months, twice per week (60 minutes per session).
| Study group | Role | What they receive |
|---|---|---|
| Active group (under physical training) | Experimental | Subjects belonging to this arm underwent physical training for three months, twice per week (60 minutes per session). Receives: Other: Physical training |
| Passive group (no physical training) | No intervention | Subjects served as controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinetti test
The 3-likert test assesses balance and gait abilities with an individual sitting in an armless chair, rising up, staying standing, turning 360° and then sitting back down. Gait is scored over 12 and balance is scored over 16, totalling 28 points.
Measured: Approximately 10-15 minutes
Berg Balance Scale
The 14-item 5-likert (from 0 to 4) scale objectively determines a patient's balance ability during a series of predetermined tasks. Scores of each item are summed up: the total score ranges from 0 to 56. The lowest the score the lowest is the level of function, the highest the score the highest is the level of function.
Measured: Approximately 20 minutes
6-minute walking test
This test is a sub-maximal exercise used to evaluate aerobic capacity and endurance.
Measured: 6 minutes
Timed up and go test
The test measures abilities of a patient initially in a seated position The patient is then asked to stand up up, walk 3 meters, turn around, walk back to the chair and sit down.
Measured: Approximately 14 seconds
"Walking While Talking" test
This test is a dual-task test, consisting in walking while reciting the alphabet or alternate letters of the alphabet.
Measured: Approximately 1 minute
Red blood cell count
Assessed with routine blood/biochemical assays
Measured: Approximately 10-15 minutes
White blood cell count
Assessed with routine blood/biochemical assays
Measured: Approximately 10-15 minutes
Hemoglobin
Assessed with routine blood/biochemical assays
Measured: Approximately 10-15 minutes
Platelet count
Assessed with routine blood/biochemical assays
Measured: Approximately 10-15 minutes
Hematocrit
Assessed with routine blood/biochemical assays
Measured: Approximately 10-15 minutes
Triglycerides
Assessed with routine blood/biochemical assays
Measured: Approximately 10-15 minutes
Cholesterol
Assessed with routine blood/biochemical assays
Measured: Approximately 10-15 minutes
Total bilirubin
Assessed with routine blood/biochemical assays
Measured: Approximately 10-15 minutes
AST (aspartate aminotransferase)
Assessed with routine blood/biochemical assays
Measured: Approximately 10-15 minutes
ALT (alanine aminotransferase)
Assessed with routine blood/biochemical assays
Measured: Approximately 10-15 minutes
Blood pressure
Assessed with routine blood/biochemical assays
Measured: Approximately 10-15 minutes
Creatinine
Assessed with routine blood/biochemical assays
Measured: Approximately 10-15 minutes
Urea
Assessed with routine blood/biochemical assays
Measured: Approximately 10-15 minutes
Glucose
Assessed with routine blood/biochemical assays
Measured: Approximately 10-15 minutes
Sodium
Assessed with routine blood/biochemical assays
Measured: Approximately 10-15 minutes
Calcium
Assessed with routine blood/biochemical assays
Measured: Approximately 10-15 minutes
Potassium
Assessed with routine blood/biochemical assays
Measured: Approximately 10-15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start1 Mar 2017
- Primary completion1 Jul 2017
- Study completion15 Nov 2017
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
- Model description
- Non-pharmacological interventional study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maamer Slimani, University of Genova
- Investigators
- Nicola L Bragazzi, MD, PhD, MPH, Principal investigator, Universita degli Studi di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981159
- Sponsor's protocol ID
- ExCiTE-A-17-0020
- Acronym
- ExCiTE-A
- Status last verified
- Jun 2019
- First submitted
- 3 Mar 2019
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Training on Biochemical and Gait/Balance Parameters in Alzheimer's Patients
- ClinicalTrials.gov ID
- NCT03981159
- Acronym / sponsor ID
- ExCiTE-A / ExCiTE-A-17-0020
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 10 Jun 2019 (actual)
- 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.
The objective of this study was to examine the effects of exercise training on physical function and biochemical markers in elderly Alzheimer's disease patients.
Detailed description
Alzheimer's disease is a neurodegenerative disease characterized by progressive and irreversible degeneration of nerve cells. The loss of these cells leads to the continuous decline in muscle function with alterations in biochemical and haematological parameters. The objective of this study was to examine the effects of exercise training on physical function and biochemical markers in elderly Alzheimer's disease patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Non-pharmacological interventional study
| Arm | Type | Receives |
|---|---|---|
| Active group (under physical training) | Experimental | Other: Physical trainingSubjects belonging to this arm underwent physical training for three months, twice per week (60 minutes per session). |
| Passive group (no physical training) | No intervention | –Subjects served as controls. |
Who may qualify
- Ages
- 80 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Subjects with official diagnosis of Alzheimer's disease;
- Subjects with MMSE higher than12.
Key exclusion criteria (1 listed)
- Subjects with MMSE below 12 (indicating severe dementia and impairment).
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 |
|---|---|---|
| Physical trainingPhysical training for three months, twice per week (60 minutes per session). | Other | Active group (under physical training) |
Primary outcome
Tinetti test
Time frame: Approximately 10-15 minutes
The 3-likert test assesses balance and gait abilities with an individual sitting in an armless chair, rising up, staying standing, turning 360° and then sitting back down. Gait is scored over 12 and balance is scored over 16, totalling 28 points.
Berg Balance Scale
Time frame: Approximately 20 minutes
The 14-item 5-likert (from 0 to 4) scale objectively determines a patient's balance ability during a series of predetermined tasks. Scores of each item are summed up: the total score ranges from 0 to 56. The lowest the score the lowest is the level of function, the highest the score the highest is the level of function.
6-minute walking test
Time frame: 6 minutes
This test is a sub-maximal exercise used to evaluate aerobic capacity and endurance.
Timed up and go test
Time frame: Approximately 14 seconds
The test measures abilities of a patient initially in a seated position The patient is then asked to stand up up, walk 3 meters, turn around, walk back to the chair and sit down.
"Walking While Talking" test
Time frame: Approximately 1 minute
This test is a dual-task test, consisting in walking while reciting the alphabet or alternate letters of the alphabet.
Red blood cell count
Time frame: Approximately 10-15 minutes
Assessed with routine blood/biochemical assays
White blood cell count
Time frame: Approximately 10-15 minutes
Assessed with routine blood/biochemical assays
Hemoglobin
Time frame: Approximately 10-15 minutes
Assessed with routine blood/biochemical assays
Platelet count
Time frame: Approximately 10-15 minutes
Assessed with routine blood/biochemical assays
Hematocrit
Time frame: Approximately 10-15 minutes
Assessed with routine blood/biochemical assays
Triglycerides
Time frame: Approximately 10-15 minutes
Assessed with routine blood/biochemical assays
Cholesterol
Time frame: Approximately 10-15 minutes
Assessed with routine blood/biochemical assays
Total bilirubin
Time frame: Approximately 10-15 minutes
Assessed with routine blood/biochemical assays
AST (aspartate aminotransferase)
Time frame: Approximately 10-15 minutes
Assessed with routine blood/biochemical assays
ALT (alanine aminotransferase)
Time frame: Approximately 10-15 minutes
Assessed with routine blood/biochemical assays
Blood pressure
Time frame: Approximately 10-15 minutes
Assessed with routine blood/biochemical assays
Creatinine
Time frame: Approximately 10-15 minutes
Assessed with routine blood/biochemical assays
Urea
Time frame: Approximately 10-15 minutes
Assessed with routine blood/biochemical assays
Glucose
Time frame: Approximately 10-15 minutes
Assessed with routine blood/biochemical assays
Sodium
Time frame: Approximately 10-15 minutes
Assessed with routine blood/biochemical assays
Calcium
Time frame: Approximately 10-15 minutes
Assessed with routine blood/biochemical assays
Potassium
Time frame: Approximately 10-15 minutes
Assessed with routine blood/biochemical assays
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 10 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Nicola L Bragazzi, MD, PhD, MPH principal investigator
Universita degli Studi di Genova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training in people with Alzheimer Disease, run by University of Genova at 1 site in Italy.
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 2 inclusion and 1 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 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
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?
Tinetti test (time frame: Approximately 10-15 minutes). The study lists 22 primary outcomes in all. 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 10 Jun 2019.