Effects of Exercise and Rivastigmine on Quality of Life of Alzheimer's Disease Patients

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

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: Rivastigmine; Other: Exercise training program

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Bahia
    • Salvador, Bahia, Brazil, 40.110-170
      • Ferderal University of Bahia - DINEP
    • Salvador, Bahia, Brazil, 40110170
      • Federal University of Bahia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rivastigmine and exercise program; 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	Drug: Rivastigmine; All patients start on a 5-cm2 rivastigmine transdermal patch and their dose is progressively increased; Other Names: Rivastigmine use; Other: Exercise training program; Exercise training program; Other Names: Rivastigmine use and exercise program
Active Comparator: Rivastigmine; Control group : Rivastigmine All patients will monthly receive Rivastigmine (Exelon patch)	Drug: Rivastigmine; All patients start on a 5-cm2 rivastigmine transdermal patch and their dose is progressively increased; Other Names: Rivastigmine use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' Quality of life	Patients' Quality of life of assessed by Quality of life scale in Alzheimer's disease (QOL-AD)- Portuguese version	Monthly for six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognition	Cognition change, through Mini-Mental State examination (MMSE)	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	Monthly for six months
Activities of daily living	Activities of daily living, through Activities of Daily Living Questionnaire of Alzheimer disease - portuguese version	Monthly for six months
Functional mobility	Functional mobility, through Time Up and Go test	Monthly for six months

Collaborators and Investigators

• Sponsor: Federal University of Bahia
• Investigators: Study Chair: Paula Aguiar, Federal University of Bahia

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: August 16, 2010
• First Submitted That Met QC Criteria: August 17, 2010
• First Posted (Estimate): August 18, 2010

Study Record Updates

• Last Update Posted (Estimate): March 20, 2012
• Last Update Submitted That Met QC Criteria: March 19, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Exercise; Alzheimer's disease; Quality of life; Rivastigmine
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Neuroprotective Agents; Protective Agents; Cholinesterase Inhibitors; Rivastigmine
• Other Study ID Numbers: PA-01