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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01183806
• Other study ID #: PA-01
• Status: Completed
• Phase: Phase 3
• First received: August 16, 2010
• Last updated: March 19, 2012
• Start date: July 2010
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Federal University of Bahia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Rivastigmine
All patients start on a 5-cm2 rivastigmine transdermal patch and their dose is progressively increased

Other:
• Exercise training program
Exercise training program

Locations

Country	Name	City	State
Brazil	Federal University of Bahia	Salvador	Bahia
Brazil	Ferderal University of Bahia - DINEP	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Bahia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Cognition	Cognition change, through Mini-Mental State examination (MMSE)	Monthly for six months	No
Secondary	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	No
Secondary	Activities of daily living	Activities of daily living, through Activities of Daily Living Questionnaire of Alzheimer disease - portuguese version	Monthly for six months	No
Secondary	Functional mobility	Functional mobility, through Time Up and Go test	Monthly for six months	No