Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-29 @ 4:19 PM
Study NCT ID:
NCT01183806
Status:
COMPLETED
Last Update Posted:
2012-03-20
First Post:
2010-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Exercise and Rivastigmine on Quality of Life of Alzheimer's Disease Patients
Sponsor:
Federal University of Bahia
Organization:
Study Overview
Official Title:
Effects of Exercise and Rivastigmine on Quality of Life of Alzheimer's Disease Patients
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: