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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ailton de Souza Melo, Federal University of Bahia
ClinicalTrials.gov Identifier:
NCT01183806
First received: August 16, 2010
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Alzheimer Disease
Drug: Rivastigmine
Other: Exercise training program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Exercise and Rivastigmine on Quality of Life of Alzheimer's Disease Patients

Resource links provided by NLM:


Further study details as provided by Federal University of Bahia:

Primary Outcome Measures:
  • Patients' Quality of life [ Time Frame: Monthly for six months ] [ Designated as safety issue: No ]
    Patients' Quality of life of assessed by Quality of life scale in Alzheimer's disease (QOL-AD)- Portuguese version


Secondary Outcome Measures:
  • Cognition [ Time Frame: Monthly for six months ] [ Designated as safety issue: No ]
    Cognition change, through Mini-Mental State examination (MMSE)

  • Caregivers' Quality of life [ Time Frame: Monthly for six months ] [ Designated as safety issue: No ]
    Caregivers' Quality of life of assessed by Quality of life scale in Alzheimer's disease (QOL-AD)- Portuguese version

  • Activities of daily living [ Time Frame: Monthly for six months ] [ Designated as safety issue: No ]
    Activities of daily living, through Activities of Daily Living Questionnaire of Alzheimer disease - portuguese version

  • Functional mobility [ Time Frame: Monthly for six months ] [ Designated as safety issue: No ]
    Functional mobility, through Time Up and Go test


Enrollment: 40
Study Start Date: July 2010
Study Completion Date: March 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Rivastigmine use
Other: Exercise training program
Exercise training program
Other Name: 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 Name: Rivastigmine use

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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183806

Locations
Brazil
Federal University of Bahia
Salvador, Bahia, Brazil, 40110170
Ferderal University of Bahia - DINEP
Salvador, Bahia, Brazil, 40.110-170
Sponsors and Collaborators
Federal University of Bahia
Investigators
Study Chair: Paula Aguiar Federal University of Bahia
  More Information

No publications provided by Federal University of Bahia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ailton de Souza Melo, Ailton de Souza Melo,PhD, Federal University of Bahia
ClinicalTrials.gov Identifier: NCT01183806     History of Changes
Other Study ID Numbers: PA-01
Study First Received: August 16, 2010
Last Updated: March 19, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Bahia:
Alzheimer's disease
Exercise
Rivastigmine
Quality of life

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Rivastigmine
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014