Effects of Exercise and Rivastigmine on Quality of Life of Alzheimer's Disease Patients
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Rivastigmine
Exercise training program
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's disease, Exercise, Rivastigmine, Quality of life
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Ferderal University of Bahia - DINEP
- Federal University of Bahia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rivastigmine and exercise program
Rivastigmine
Arm Description
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
Control group : Rivastigmine All patients will monthly receive Rivastigmine (Exelon patch)
Outcomes
Primary Outcome Measures
Patients' Quality of life
Patients' Quality of life of assessed by Quality of life scale in Alzheimer's disease (QOL-AD)- Portuguese version
Secondary Outcome Measures
Cognition
Cognition change, through Mini-Mental State examination (MMSE)
Caregivers' Quality of life
Caregivers' Quality of life of assessed by Quality of life scale in Alzheimer's disease (QOL-AD)- Portuguese version
Activities of daily living
Activities of daily living, through Activities of Daily Living Questionnaire of Alzheimer disease - portuguese version
Functional mobility
Functional mobility, through Time Up and Go test
Full Information
NCT ID
NCT01183806
First Posted
August 16, 2010
Last Updated
March 19, 2012
Sponsor
Federal University of Bahia
1. Study Identification
Unique Protocol Identification Number
NCT01183806
Brief Title
Effects of Exercise and Rivastigmine on Quality of Life of Alzheimer's Disease Patients
Official Title
Effects of Exercise and Rivastigmine on Quality of Life of Alzheimer's Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Bahia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer's disease, Exercise, Rivastigmine, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rivastigmine and exercise program
Arm Type
Experimental
Arm Description
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
Arm Title
Rivastigmine
Arm Type
Active Comparator
Arm Description
Control group : Rivastigmine All patients will monthly receive Rivastigmine (Exelon patch)
Intervention Type
Drug
Intervention Name(s)
Rivastigmine
Other Intervention Name(s)
Rivastigmine use
Intervention Description
All patients start on a 5-cm2 rivastigmine transdermal patch and their dose is progressively increased
Intervention Type
Other
Intervention Name(s)
Exercise training program
Other Intervention Name(s)
Rivastigmine use and exercise program
Intervention Description
Exercise training program
Primary Outcome Measure Information:
Title
Patients' Quality of life
Description
Patients' Quality of life of assessed by Quality of life scale in Alzheimer's disease (QOL-AD)- Portuguese version
Time Frame
Monthly for six months
Secondary Outcome Measure Information:
Title
Cognition
Description
Cognition change, through Mini-Mental State examination (MMSE)
Time Frame
Monthly for six months
Title
Caregivers' Quality of life
Description
Caregivers' Quality of life of assessed by Quality of life scale in Alzheimer's disease (QOL-AD)- Portuguese version
Time Frame
Monthly for six months
Title
Activities of daily living
Description
Activities of daily living, through Activities of Daily Living Questionnaire of Alzheimer disease - portuguese version
Time Frame
Monthly for six months
Title
Functional mobility
Description
Functional mobility, through Time Up and Go test
Time Frame
Monthly for six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Aguiar
Organizational Affiliation
Federal University of Bahia
Official's Role
Study Chair
Facility Information:
Facility Name
Ferderal University of Bahia - DINEP
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40.110-170
Country
Brazil
Facility Name
Federal University of Bahia
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40110170
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
24938502
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Exercise and Rivastigmine on Quality of Life of Alzheimer's Disease Patients
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