Ignite Creation Date:
2024-05-06 @ 7:19 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02510833
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2015-07-27
Brief Title:
Effects of Home Therapeutic Exercises Oriented for Patients With Parkinsons Disease
Sponsor:
Universidade Federal de Pernambuco
Organization:
Universidade Federal de Pernambuco
Study Overview
Official Title:
Home Therapeutic Exercises Oriented for People With Parkinsons Disease Impact on the Disease and Quality of Life
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HTE
Brief Summary:
Parkinsons 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 Parkinsons 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 Parkinsons disease UPDRS - subscales II and III and Parkinsons 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-Parkinsons 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 Parkinsons disease and quality of life
Primary objective
To evaluate the impact of home therapeutic exercises oriented in people with Parkinsons 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 Parkinsons 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 September2015 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 Parkinsons disease UPDRS - subscales II and III and Parkinsons 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 patients 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 HCUFPE 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 160 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 005 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 discDVD 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
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 Parkinsons disease and quality of life
Primary objective
To evaluate the impact of home therapeutic exercises oriented in people with Parkinsons 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 Parkinsons 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 September2015 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 Parkinsons disease UPDRS - subscales II and III and Parkinsons 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 patients 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 HCUFPE 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 160 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 005 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 discDVD 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None