Study of the Effects of Three Exercise Programs in Parkinson's Disease

NCT02622737 | Terminated

• 1 other identifier: CAAE # 41228415.5.0000.5662
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Population aging is associated with increased prevalence of chronic diseases. Parkinson's disease (PD) is the second most common neurodegenerative disease in the world population, affecting motor function and functional independence progressively. The physiological aging promotes the gradual reduction of body weight, lung function, peripheral muscle strength, cardiopulmonary endurance and physical capacity, which increase the debilitating effects. Aging, when associated with PD, can induce loss of functionality, postural changes, further affecting the nutritional status, worsening the quality of life and functional independence of the individual. Although physical therapy is commonly applied with a variety of methodologies to PD patients, evidence for the effectiveness of these interventions is lacking. Objective: The primary objective of the study is to compare the effects of Functional Training, Stationary Bike and Exergaming Exercises on proportion of fallers in elderly participants with PD. In addition, the secondary objectives are to compare the effects on cardiopulmonary endurance, posture, postural control, executive function, quality of life and functionality of individuals with PD. Methodology: This is an interventional, randomized, blinded, longitudinal and prospective study. This research will be conducted in the State Reference Center for Health Care of the Elderly (CREASI). The sample will consist of 63 individuals with PD per group. The Experimental Group 1 will be submitted to Functional Training, the Experimental Group 2 with undergo training with Stationary Bike and the Experimental Group 3 will be submitted to exergame training using Xbox360 with KinectTM sensor. All the interventions will be performed three times per week, with 50 minutes per session, during 8 weeks.

Conditions

Parkinson Disease

Keywords

Parkinson disease; Accidental Falls; Exercise therapy; Virtual Reality Exposure Therapy

Outcome Measures

Primary Outcomes (1)

• Proportion of recurrent fallers (2 or more falls over the study period)

  6 months after completion of the exercise training

Secondary Outcomes (10)

• Proportion of recurrent fallers (2 or more falls over the study period)

  3 months

• Number of falls

  6 months

• 6-Minute Walk Test (cardiovascular endurance)

  8 weeks

• Get Up and Down Test

  8 weeks

• 10 meters test (gait speed)

  8 weeks

Study Arms (3)

Functional Training

EXPERIMENTAL

Functional exercise training program

Other: Functional training

Stationary Bike

EXPERIMENTAL

Stationary bike training program

Device: Stationary bike

Exergaming

EXPERIMENTAL

Virtual Reality Exposure Therapy

Device: Exergaming

Interventions

Functional training OTHER

Three times per week, with 50 minutes per session, during 8 weeks of training activities involving 10 minutes of muscle stretching, 5 minutes of warm-up exercise, 30 minutes of a functional training and 5 minutes of respiratory exercises.

Functional Training

Stationary bike DEVICE

Three times per week, with 50 minutes per session, during 8 weeks of training activities involving 10 minutes of muscle stretching, 5 minutes of warm-up exercise, 30 minutes of a Stationary Bike exercise and 5 minutes of respiratory exercises.

Stationary Bike

Exergaming DEVICE

Three times per week, with 50 minutes per session, during 8 weeks of training activities involving 10 minutes of muscle stretching, 5 minutes of warm-up exercise, 30 minutes of a Virtual Reality exercise (performed by Xbox360 with KinectTM sensor) and 5 minutes of respiratory exercises.

Also known as: Virtual Reality Exposure Therapy

Exergaming

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Regular use of medication for PD;
• Age greater than or equal to 60 years;
• Stage 2, 2.5 or 3 according to the modified Hoehn and Yahr classification;
• Signed informed consent.

You may not qualify if:

• neurodegenerative diseases other than Parkinson disease; dementia; muscle diseases that preclude the practice of physical activity; chronic uncontrolled disease (hypertension, diabetes mellitus, chronic pain); unstable cardiovascular disease (acute heart failure, myocardial recent infarction, unstable angina and uncontrolled arrhythmia); using alcohol and other toxic substances; contraindications for performing exercise according the criteria of the American College of Sports Medicine; to practice or have practiced physical exercise program in the last six months; to participate or have participated in regular resistance training (eg, 2-3 times per week) in the previous 12 months.

Sponsors & Collaborators

• Federal University of Bahia: lead

Study Sites (1)

Centro de Referencia Estadual de Atencao a Saude do Idoso (CREASI)

Salvador, Estado de Bahia, 41820000, Brazil

Location

Related Publications (4)

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  PMID: 38588457 DERIVED

• Duarte GP, Ferraz DD, Trippo KV, Novais MCM, Sales M, Ribeiro NMDS, Oliveira Filho J. Effects of three physical exercise modalities on respiratory function of older adults with Parkinson's disease: A randomized clinical trial. J Bodyw Mov Ther. 2023 Oct;36:425-431. doi: 10.1016/j.jbmt.2023.05.014. Epub 2023 Aug 23.

  PMID: 37949595 DERIVED

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

• Ferraz DD, Trippo KV, Duarte GP, Neto MG, Bernardes Santos KO, Filho JO. The Effects of Functional Training, Bicycle Exercise, and Exergaming on Walking Capacity of Elderly Patients With Parkinson Disease: A Pilot Randomized Controlled Single-blinded Trial. Arch Phys Med Rehabil. 2018 May;99(5):826-833. doi: 10.1016/j.apmr.2017.12.014. Epub 2018 Jan 11.

  PMID: 29337023 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jamary Oliveira-Filho, MD

  Federal University of Bahia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 26, 2015
• First Posted: December 4, 2015
• Study Start: December 14, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: October 10, 2019

Record last verified: 2019-10

Locations

BR (1)