Alzheimer DiseasePhase 3NCT01183806
Effects of Exercise and Rivastigmine on Quality of Life of Alzheimer's Disease Patients
A Phase 3 study testing Rivastigmine and Exercise training program in people with Alzheimer Disease, run by Federal University of Bahia at 2 sites in Brazil.
Trial summary
The purpose of this study is to determine whether a exercise program when combined with rivastigmine (Exelon patch) drug treatment compared with rivastigmine drug treatment alone would improve quality of life, ability to perform activities of daily living (ADL) and cognition in patients with Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Rivastigmine and Exercise training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesBrazil
- Study dates
- Jul 2010to Mar 2012
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous diagnosis of probable Alzheimer's disease
- At least 55 years of age
- Same caregiver (familiar or paid one) for at least 3 months before, who is able to follow the patient in a two-day/week exercise program
- Do not be taking other prescribed medication for Alzheimer disease
- Treated stable hypertension
Who cannot join
- Mini-Mental State Examination (MMSE) score of less than 12
- Can't follow simple commands;
- Can't answer two or more items of Quality of life questionnaire
- Practiced regular exercise or physiotherapy/ occupational therapy in the last two months.
- Diagnosed psychiatric condition (including depression).
- Use of neuroleptic drugs
- Orthopedic, neurologic, or behavioral limitations that may preclude exercise training
- Visual or hearing impairment that may preclude exercise training or comprehension
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Ferderal University of Bahia - DINEP
Salvador, Estado de Bahia, 40.110-170
Federal University of Bahia
Salvador, Estado de Bahia, 40110170
About this study
The purpose of this study is to determine whether a exercise program when combined with rivastigmine (Exelon patch) drug treatment compared with rivastigmine drug treatment alone would improve quality of life, ability to perform activities of daily living (ADL) and cognition in patients with Alzheimer's disease.
Hypothesis:
Read more
Ho: Rivastigmine drug treatment combined with exercise is not superior to rivastigmine drug treatment to improve quality of life of Alzheimer's disease patients.
H1: Rivastigmine drug treatment combined with exercise is superior to rivastigmine drug treatment to improve quality of life of Alzheimer's disease patients, with an expectative of 15% of improvement in the quality of life scale measurement
Read the detailed description
After screening and informed consent, that will be collected demographical data from patient. Another researcher will evaluate the cognition, through MMSE; the activities of daily living, through Activities of Daily Living Questionnaire of Alzheimer disease; patient and caregiver's quality of life through Quality of life scale in Alzheimer's disease (QOL-AD); functional mobility, through Time Up and Go test.
Afterwards, the pharmacist will give the medicine, orientations about its administration and clarify possible doubts. Therapy will begin with the small patch of 5 mg/24 h and, if well tolerated, the dose will be increased to the 10 mg/24 h patch.
The patients will be randomly assigned, through a computer program list, to exercise or control group. The patient and caregiver exercise group will receive information about the two-day/week exercise program at physiotherapy ambulatory. Monthly, all patients and caregiver will be clinically reevaluated during six months.
The forty minutes exercise program will include aerobic, strength, flexibility and balance training, organize in the follow sequence:
- Ten minutes of global stretching (shoulder girdle, upper limbs, lower limbs and trunk) along the beginning and final of the session. Each stretch posture will last 30 seconds.
Alternation of A and B sessions, lasting 30 minutes:
- Session A: Aerobic training on treadmill. Progression of 10 to 30 minutes of continuous aerobic activity
- Session B: - Resisted kinesiotherapy (strength training) with use of weights to be attached around the ankles and wrist of initially 1 Ib. The physiotherapist will evaluate if patient can progress to a higher weight during sessions.
- Walking over obstacles on the ground and direction change with use of cones.
- Functional activities like transfer exercise (stand/sit exercise) and squatting The monitoring of the exercise, its progress and any other observation will be register in a control form by the physiotherapist.
- Conditions
- Alzheimer Disease
- Being tested
- Rivastigmine, Exercise training program
- Keywords
- Alzheimer's disease, Exercise, Rivastigmine, Quality of life
- 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.
RivastigmineDrug
Also called Rivastigmine use
All patients start on a 5-cm2 rivastigmine transdermal patch and their dose is progressively increased
Exercise training programOther
Also called Rivastigmine use and exercise program
Exercise training program
| Study group | Role | What they receive |
|---|---|---|
| Rivastigmine and exercise program | Experimental | Experimental group: Rivastigmine and exercise program: All patients will monthly receive Rivastigmine (Exelon patch). The exercise training program consists of two 40-minute sessions per week for six months and includes aerobic, strength, flexibility and balance training Receives: Drug: Rivastigmine; Other: Exercise training program |
| Rivastigmine | Active comparator | Control group : Rivastigmine All patients will monthly receive Rivastigmine (Exelon patch) Receives: Drug: Rivastigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' Quality of life
Patients' Quality of life of assessed by Quality of life scale in Alzheimer's disease (QOL-AD)- Portuguese version
Measured: Monthly for six months
Secondary outcomes (4)
Cognition
Cognition change, through Mini-Mental State examination (MMSE)
Measured: Monthly for six months
Caregivers' Quality of life
Caregivers' Quality of life of assessed by Quality of life scale in Alzheimer's disease (QOL-AD)- Portuguese version
Measured: Monthly for six months
Activities of daily living
Activities of daily living, through Activities of Daily Living Questionnaire of Alzheimer disease - portuguese version
Measured: Monthly for six months
Functional mobility
Functional mobility, through Time Up and Go test
Measured: Monthly for six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ailton de Souza Melo, Federal University of Bahia
- Investigators
- Paula Aguiar, Study chair, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183806
- Sponsor's protocol ID
- PA-01
- Status last verified
- Mar 2012
- First submitted
- 16 Aug 2010
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Aguiar P, Monteiro L, Feres A, Gomes I, Melo A. Rivastigmine transdermal patch and physical exercises for Alzheimer's disease: a randomized clinical trial. Curr Alzheimer Res. 2014;11(6):532-7. doi: 10.2174/1567205011666140618102224.
PubMed 24938502
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise and Rivastigmine on Quality of Life of Alzheimer's Disease Patients
- ClinicalTrials.gov ID
- NCT01183806
- Acronym / sponsor ID
- PA-01
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's disease, Exercise, Rivastigmine, Quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 18 Aug 2010 (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.
The purpose of this study is to determine whether a exercise program when combined with rivastigmine (Exelon patch) drug treatment compared with rivastigmine drug treatment alone would improve quality of life, ability to perform activities of daily living (ADL) and cognition in patients with Alzheimer's disease.
Hypothesis:
Ho: Rivastigmine drug treatment combined with exercise is not superior to rivastigmine drug treatment to improve quality of life of Alzheimer's disease patients.
H1: Rivastigmine drug treatment combined with exercise is superior to rivastigmine drug treatment to improve quality of life of Alzheimer's disease patients, with an expectative of 15% of improvement in the quality of life scale measurement
Detailed description
After screening and informed consent, that will be collected demographical data from patient. Another researcher will evaluate the cognition, through MMSE; the activities of daily living, through Activities of Daily Living Questionnaire of Alzheimer disease; patient and caregiver's quality of life through Quality of life scale in Alzheimer's disease (QOL-AD); functional mobility, through Time Up and Go test.
Afterwards, the pharmacist will give the medicine, orientations about its administration and clarify possible doubts. Therapy will begin with the small patch of 5 mg/24 h and, if well tolerated, the dose will be increased to the 10 mg/24 h patch.
The patients will be randomly assigned, through a computer program list, to exercise or control group. The patient and caregiver exercise group will receive information about the two-day/week exercise program at physiotherapy ambulatory. Monthly, all patients and caregiver will be clinically reevaluated during six months.
The forty minutes exercise program will include aerobic, strength, flexibility and balance training, organize in the follow sequence:
- Ten minutes of global stretching (shoulder girdle, upper limbs, lower limbs and trunk) along the beginning and final of the session. Each stretch posture will last 30 seconds.
Alternation of A and B sessions, lasting 30 minutes:
- Session A: Aerobic training on treadmill. Progression of 10 to 30 minutes of continuous aerobic activity
- Session B: - Resisted kinesiotherapy (strength training) with use of weights to be attached around the ankles and wrist of initially 1 Ib. The physiotherapist will evaluate if patient can progress to a higher weight during sessions.
- Walking over obstacles on the ground and direction change with use of cones.
- Functional activities like transfer exercise (stand/sit exercise) and squatting The monitoring of the exercise, its progress and any other observation will be register in a control form by the physiotherapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivastigmine and exercise program | Experimental | Drug: Rivastigmine, Other: Exercise training programExperimental group: Rivastigmine and exercise program: All patients will monthly receive Rivastigmine (Exelon patch). The exercise training program consists of two 40-minute sessions per week for six months and includes aerobic, strength, flexibility and balance training |
| Rivastigmine | Active comparator | Drug: RivastigmineControl group : Rivastigmine All patients will monthly receive Rivastigmine (Exelon patch) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Previous diagnosis of probable Alzheimer's disease
- At least 55 years of age
- Same caregiver (familiar or paid one) for at least 3 months before, who is able to follow the patient in a two-day/week exercise program
- Do not be taking other prescribed medication for Alzheimer disease
- Treated stable hypertension
Key exclusion criteria (8 listed)
- Mini-Mental State Examination (MMSE) score of less than 12
- Can't follow simple commands;
- Can't answer two or more items of Quality of life questionnaire
- Practiced regular exercise or physiotherapy/ occupational therapy in the last two months.
- Diagnosed psychiatric condition (including depression).
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 |
|---|---|---|
| RivastigmineAlso: Rivastigmine useAll patients start on a 5-cm2 rivastigmine transdermal patch and their dose is progressively increased | Drug | Rivastigmine, Rivastigmine and exercise program |
| Exercise training programAlso: Rivastigmine use and exercise programExercise training program | Other | Rivastigmine and exercise program |
Primary outcome
Patients' Quality of life
Time frame: Monthly for six months
Patients' Quality of life of assessed by Quality of life scale in Alzheimer's disease (QOL-AD)- Portuguese version
4 secondary outcomes
Cognition
Time frame: Monthly for six months
Caregivers' Quality of life
Time frame: Monthly for six months
Activities of daily living
Time frame: Monthly for six months
Functional mobility
Time frame: Monthly for six 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 20 Mar 2012.
- Derived from this study: PubMed 24938502Aguiar P, Monteiro L, Feres A, Gomes I, Melo A. Rivastigmine transdermal patch and physical exercises for Alzheimer's disease: a randomized clinical trial. Curr Alzheimer Res. 2014;11(6):532-7. doi: 10.2174/1567205011666140618102224.
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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.
Paula Aguiar study chair
Federal University of Bahia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivastigmine and Exercise training program in people with Alzheimer Disease, run by Federal University of Bahia at 2 sites in Brazil.
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 5 inclusion and 8 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 20 Mar 2012. 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 Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Patients' Quality of life (time frame: Monthly for six 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 NCT01183806, which also lists 1 linked publication.
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 20 Mar 2012.