Effects of Home Therapeutic Exercises Oriented for Patients With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

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.
    

Detailed description: 
      Type of Study:

      Randomized controlled clinical trial.

      Hypothesis:

      Program-oriented home therapeutic exercises with individualized approach and weekly
      monitoring of the physical therapist contributes to the improvement of signs and symptoms of
      Parkinson's disease and quality of life.

      Primary objective:

      To evaluate the impact of home therapeutic exercises oriented in people with Parkinson's
      disease.

      Secondary objective:

        -  To investigate the knowledge, attitudes and practice about home therapeutic exercises
           oriented in the study population;

        -  Identify adhesion and barriers related to exercise program;

        -  Evaluate the impact of home-based therapeutic exercise about daily activities, motor
           exploration and the quality of life in Parkinson's disease.

      Proposed Methodology:

      Participants will be informed of the nature and purpose of the study. Then those who meet the
      eligibility criteria and wish to participate, sign the Consent Agreement and Informed (IC).
      The study will be conducted in the Pró-Parkinson Program at the Hospital das Clinicas,
      Federal University of Pernambuco (UFPE), Neurology Clinic, between December/ 2014 to
      September/2015. Will be applicable before and after 12 weeks of intervention ( medication ON
      period): 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). GIC- Initially, a physiotherapist,
      member of the Pró-Parkinson Program and responsible for this research, guide and train the
      individual patient and his companion about physiotherapy exercises present in an illustrative
      manual of the Pro-Parkinson. Also, there are lectures about the therapeutic exercises in in
      medical consultation day. The exercises should be performed in his home three times a week
      (every other day) with a maximum duration of 60 minutes each session for 12 weeks and always
      under the influence of anti-Parkinsonian medications (ON period of medication). After the
      meeting, receive the manual, if not yet available, and a daily exercises. In the diary, the
      participant or caregiver should write down the exercises, reporting the day, time, held all
      or not and difficulties for subsequent control of the responsible researcher. Participants
      will receive weekly calls from physiotherapist at the agreed time with the participant and /
      or caregiver, to remind them of the exercises, answer questions and encourage them to
      continue the practice. It is emphasized that if the participant and caregiver this are not
      able to write in the diary, the data will be questioned by the researcher in his weekly phone
      call, without prejudice to the control. Physiotherapist phone numbers will be available for
      participants in the daily exercises. GC- participants and accompanying persons may attend the
      lectures of the service (including the Physical Therapy) and have the same manual, without
      the subsequent weekly follow-up phone calls, usual service procedure. The lectures take place
      every Wednesday in day consultation, two meetings / month for the physiotherapy team. These
      have a maximum duration of 40 minutes in which patients and caregivers are instructed and
      trained to do the manual physical therapy exercises his home three times a week with a
      maximum duration of 60 minutes each session and always under the influence anti-Parkinsonian
      drugs (ON period of the medication). At the end of the talks, the manual is available. The
      lectures are given by physiotherapists, properly trained, the Pro-Parkinson Program members.
      The Pro-Parkinson manual, distributed in the program since 2012, covers chapters with
      exercises and guidelines of medical areas, physiotherapy, speech therapy, occupational
      therapy and dentistry. The physiotherapy section (page 10-21) includes stretching exercises,
      mobility, balance and strength, plus the guidelines. It has general instructions for the
      exercises; the sequence describing the same, self-explanatory illustrations and the number of
      sets and reps / maintenance time to be realized. All exercises are designed so they could be
      carried out independently and safely in the patient's home. Patients will be instructed to
      make them with clothes that let free knees and sneakers or shoes (if there jump up to 2 cm)
      that are attached to the ankle. The exercises will be supervised by the patient or caregiver,
      own if necessary.

      Risks:

      With regard to the questionnaires, there may be the risk of embarrassment. To minimize the
      same, the data collection will be held individually and enabling environment for data
      confidentiality. If refuses to answer any question, no insistence, as well as any damage to
      the participant. Pain, muscle discomfort or fatigue may occur during and after the exercises,
      however, the patient will be advised to discontinue the exercises try a case considered
      unbearable pain. To minimize these risks, the whole exercise program will be guided to be
      held in range of motion and pain-free intensity for the safety. During the exercises, you can
      also change the cardiorespiratory parameters such as blood pressure and respiratory rate. In
      an attempt to minimize risk, will not participate in the study those who submit changes in
      blood pressure levels and heart rate and respiratory considered beyond normal.

      Benefits:

      The direction of this study will bring direct benefits to patients attending the service in
      order to be a population with few resources to finance a rehabilitation treatment, or with
      little or no access to such services as with patients in the state . This diagnosis of the
      study population are described in Coriolanos et al. (2013) that describing the
      epidemiological profile of patients with PD at HC/UFPE. Moreover, the results will contribute
      to evidence-based therapeutic practice and the literary collection, fostering new studies.

      Data Analysis Methodology:

      All study collections will be held at Pró-Parkinson Program at the Hospital das Clinicas,
      Federal University of Pernambuco (UFPE), Neurology Clinic, and each variable will be
      evaluated by the responsible employees and physiotherapist, who will undergo a period of
      training. Outcomes will be analyzed using statistical software SPSS version 16.0 (SPSS Inc,
      Chicago, IL, USA). To verify the normality of the sample, the Shapiro-Wilk test is used. Upon
      proof of normality, the results before and after the intervention will be compared within
      groups, paired analysis, by means of the Wilcoxon test and intergroup, independent analysis,
      using the Mann-Whitney test. To analyze the results of the Survey CAP and Adhesion, the
      descriptive statistics from the frequency calculations will be made, high-low, median, mean,
      standard deviation. The significance level is 0.05 on all analyses. Datas and images through
      photographs will be stored on the personal computer of responsible physical therapist and
      counselor, and there are two copies on CD compact disc/DVD. The responsibility of
      confidentiality of data is the responsible physiotherapist.

      Sample Size in Brazil: 28 (14 in the intervention group and 14 for control). To carry out the
      sample size calculation, the investigators used the statistical program PASS (Power Analysis
      and Sample Size), version 2005. After simulations, the investigators chose a minimum sample
      size of 14 patients in the control group and 14 for the intervention group, totaling 28
      patients. This number is capable of detecting, with a 82% test power and 5% significance
      level, a reduction of 3 points in the PDQ-39 scale and UPDRS-Motor for the intervention group
      compared with no reduction for the control group, using a one-tailed parametric or
      non-parametric test for independent samples, considering the standard deviation of the
      reduction on the order of 3 points to the two groups. For all calculations, the mean and
      standard deviation parameters were expected based on studies Lun et al. (2005), Dereli and
      Yaliman (2010), Navarro-Peternella and Marcon (2012), as well as clinical experience
      Pró-Parkinson.
    

Intervention name(s): Exercises oriented, manual and monitoring by phone; Exercises oriented, manual and without monitoring by phone
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Parkinson Disease; Physical Therapy Modalities; Quality of Life; Self Care