Effects of Home Therapeutic Exercises Oriented for Patients With Parkinson's Disease

NCT02510833 | Completed DMC

• 1 other identifier: CAAE- 38511314000005208
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

Parkinson's disease (PD), neurodegenerative and common from 50 to 60 years, is characterized by rigidity, bradykinesia and resting tremor that can interfere in the quality of life. To maintain or improve this, there is the physiotherapy. Problems in access, such as walking and financial difficulties, make home exercises target of interest. The study aims to assess the impact of a program of home therapeutic exercises, with individualized approach and remote monitoring by physical therapist, about signs and symptoms of Parkinson's disease and quality of life. This is a randomized controlled clinical trial, conducted at the Program Pró-Parkinson of the Clinics Hospital, Federal University of Pernambuco, Neurology Clinic. Will be included people of both sexes (50 years) with idiopathic PD, stages 1-3 in Hoehn \& Yahr original; non-institutionalized and independent walking. It will be applied before and after 12 weeks of intervention (period ON of medication): Survey about Knowledge, Attitudes and Practice; Questionnaire of Accession; Unified Scale Evaluation of Parkinson's disease (UPDRS) - subscales II and III; and Parkinson's Disease Questionnaire 39 (PDQ-39). Participants will be randomized into two groups: Group continued intervention (GIC) and control group (CG). The GIC will have an meeting with individualized approach (physical therapist, patient and companion) for guidance on home physical therapy exercises, using the Manual Pró-Parkinson, then the participant will receive the manual with stretching exercises, mobility, balance and strength, which will lead to your home as a way to guide their activities; and receive weekly follow-up by phone calls (to remember the exercises, answer questions and encourage the continued practice). GC may be attend presentations on home exercises of the Pro-Parkinson's manual in the days of your query and have the same manual without remote follow-up by phone calls, usual service procedure. Exercises are oriented to be performed three times a week for 12 weeks and under the effect of anti-Parkinson medication. This study will contribute new evidence on the effects of a rehabilitation program available and inexpensive based on home exercises.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Physical Therapy Modalities; Quality of Life; Self Care

Outcome Measures

Primary Outcomes (2)

• Unified Scale Evaluation of Parkinson's disease (UPDRS)

  Standard evaluation to measure the signs and symptoms in practice and clinical research in PD. It consists of 42 items divided into four subscales: I- mentation, behavior and mood; II activities of daily living (ADLs); III motor operation and IV complications of drug therapy. For this study will be used only subscales II and III, with a view to clinical evaluation with a focus on activities of daily living and motor operation. The score for each item ranges from 0 to 4, and the maximum value indicates greater commitment by the disease.

  3 months

• Parkinson's Disease Questionnaire 39 (PDQ-39)

  The PDQ-39 is a specific tool to assess quality of life in PD. Comprises 39 items divided into eight dimensions: mobility, activities of daily living (ADLs), emotional well-being, stigma, social support, cognition, communication and physical discomfort, where scores range from 0-100, with the higher, the worse the perception of quality of life.

  3 months

Secondary Outcomes (2)

• Survey about Knowledge, Attitudes and Practice (CAP)

  3 months

• Questionnaire on Barriers identification for Accession

  3 months

Study Arms (2)

Continuing Intervention Group

EXPERIMENTAL

Behavioral: Exercises oriented, manual and monitoring by phone

Control Group

ACTIVE COMPARATOR

Behavioral: Exercises oriented, manual and without monitoring by phone

Interventions

Exercises oriented, manual and monitoring by phone BEHAVIORAL

Individual meeting to guide therapeutic exercises (stretching, mobility, balance and strength), manual with these exercises for support in practice at home and weekly monitoring by phone. Patients will be oriented to do exercises three times per week for twelve weeks.

Continuing Intervention Group

Exercises oriented, manual and without monitoring by phone BEHAVIORAL

Lectures (optatives) about therapeutic exercises (stretching, mobility, balance and strength) in days of medical consultation, manual with these exercises for support in practice at home, without weekly monitoring by phone. Patients will be oriented to do exercises three times per week for twelve weeks.

Control Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People female and male; not institutionalized; aged between 50 and 80 years; diagnosed with idiopathic PD attested by the service neurologist in mild to moderate stages (classified from 1 to 3) in accordance with the original version of the scale of Hoehn \& Yahr (HOEHN \& Yahr, 1967); independent gait (without assistance)..

You may not qualify if:

• Those with cognitive impairment identified by the Mini Mental State Examination (MMSE) (Folstein \& MC HUGH, 1975), whose cutoff point for illiterate individuals will be 18/19 and for individuals with schooling will be 24/25 (LOURENCO \& VERAS, 2006 ); other neurological disorders, orthopedic limiting or unstable cardiopulmonary associated; with any medical contraindication to exercise or musculoskeletal and do physical therapy.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Related Publications (1)

• CORIOLANO MGWS et al. Perfil epidemiológico dos pacientes com doença de parkinson do Hospital das Clínicas da Universidade Federal de Pernambuco. Neurobiologia, 76 (1-2) jan./jun., 2013. DERELI EE, YALIMAN A. Comparison of the effects of a physiotherapist-supervised exercise programme and a self-supervised exercise programme on quality of life in patients with Parkinson's disease. Clin Rehabil. 2010;24(4):352-62. LUN, V. et al. Comparison of the effects of a self-supervised home exercise program with a physiotherapist-supervised exercise program on the motor symptoms of Parkinson's disease. Mov Dis, v. 20, n. 8, p. 971-5, 2005. NAVARRO-PETERNELLA, F. M.; MARCON, S. S. Qualidade de vida de indivíduos com Parkinson e sua relação com tempo de evolução e gravidade da doença. Rev. Latino-Am. Enfermagem, v. 20, n. 2, 2012.

  BACKGROUND

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

• IHANA GONDIM

  Universidade Federal de Pernambuco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: IHANA THAÍS GUERRA DE OLIVEIRA GONDIM

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: July 29, 2015
• Study Start: January 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 20, 2016

Record last verified: 2016-01