Clinical trial NCT01183806: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer Disease
Keywords: Alzheimer's disease
Exercise
Rivastigmine
Quality of life
Lead sponsor: Federal University of Bahia
Sponsor class: OTHER
First posted: 2010-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patients' Quality of life
timeFrame: Monthly for six months
Secondary outcomes:
measure: Cognition
timeFrame: Monthly for six months
measure: Caregivers' Quality of life
timeFrame: Monthly for six months
measure: Activities of daily living
timeFrame: Monthly for six months
measure: Functional mobility
timeFrame: Monthly for six months
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Ferderal University of Bahia - DINEP
state: Bahia
city: Salvador
country: Brazil
facility: Federal University of Bahia
state: Bahia
Study officials:
affiliation: Federal University of Bahia
name: Paula Aguiar
role: STUDY_CHAIR
References:
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.