Back to resultsThe Effect of Resistance Training in Parkinson Disease: A Pilot Study
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Gym Group
Free Weights Group
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Resistance Training, Postural Balance, Exercise
Eligibility Criteria
Inclusion Criteria:
- Age between 50 to 75 years old;
- Hoehn and Yahr stages II or III;
- Idiopathic Parkinson disease diagnosed according to the United Kingdom Parkinson's Disease Society Brain Research Centre Criteria, Institute of Neurology, London;
- Ability to walk independently without walking devices aid;
- Absence of orthopedic injuries or pain in joints that could interfere on training program;
- Stable medication regimen for PD treatment at recruitment stage;
- Mini Mental State Examination Scale (MMSE) ≥ to 27 for literate patients and schooling ≥ of 4 years of formal education;
- No cardiovascular instability;
- No pacemaker, decompensated metabolic disease, vestibular dysfunction, and stroke;
- Availability to come to the clinic twice a week;
- Not participating in other physical rehabilitation programs during and six months prior to the study.
Exclusion Criteria:
- Patients will be excluded if they refuse to participate, do not sign the consent form, have a diagnosis of secondary parkinsonism or present cognitive impairment.
Sites / Locations
- Department of Neurology of University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Gym Group
Free Weights Group
Control Group
Arm Description
With gym equipments, twice per week for 12 weeks.
With dumbbells, elastics, twice per week for 12 weeks.
The control group will be instructed to perform stretching exercises at home in the same 12-week period, according to an illustrated booklet.
Outcomes
Primary Outcome Measures
Postural sway on Static Posturography
Static Posturography is a technique used to objectively assess postural sway with patients standing still on a fixed platform that measures center of pressure displacement. Tests were standardized such as the feet position, the eye gaze and environment light, with three trials of 60-second test in eyes - open, eyes closed and eyes open in dual task condition. Investigators will analyze the anteroposterior displacement, medial-lateral displacement, area, velocity and path length.
Secondary Outcome Measures
Balance on Berg Balance Scale
Berg Balance Scale is used to assess balance and falls in elderly using different tasks. It consists of 14 tasks scoring from zero to four, zero means that the patient is unable to perform the task and four means that the task is performed independently.
Balance Evaluation on Mini-BESTest
The Mini-BESTest contains 14 items that assess dynamic balance focusing on anticipatory postural adjustments, postural responses, sensory orientation and stability in gait. Items are scored from 0 to 2 (normal performance in balance).
Functional balance and gait on Timed Up and Go test (TUG)
The TUG test measures individual speed while performing the sequence: rising from a chair, walking for three meters of distance, turning around and returning to the starting position, sitting on a chair. When the examination exceeds 13 seconds, patients have higher risk of falls.
Quality of life on PDQ-39 Questionnaire
The PDQ-39 assess quality of life of Parkinson's disease patients over the last month. Contains 39 items and eight dimensions (Mobility, Activities of daily living, Emotional well-being, Stigma, Social support, Cognitions and Bodily discomfort).
Functional balance on Dynamic Posturography
Dynamic posturography is a quantitative method to assess balance. This system have sensors located below two platforms and measures vertical and horizontal forces produced by the center of gravity during a pre-determined task (sit to stand, tandem walk and step over).
Full Information
NCT ID
NCT02674724
First Posted
January 14, 2016
Last Updated
April 17, 2019
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02674724
Brief Title
The Effect of Resistance Training in Parkinson Disease: A Pilot Study
Official Title
The Effect of Resistance Training on Balance in Patients With Parkinson Disease: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
October 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate if resistance training exercises performed twice a week with or without gym equipment assistance in a 12-week period could improve balance in patients with Parkinson Disease (PD).
Methods: Sixty three patients with idiopathic PD (Hoehn and Yahr stage II - III) and preserved cognitive function will participate in this study. Patients will be randomized among three intervention groups: resistance training with free weights, resistance training with gym equipment and control group. Investigators will use static platform balance variables to assess the primary end-point outcome measures. For the secondary outcomes measures, most common clinical functional balances tests for PD will be applied: Berg Balance Scale (BBS), Mini-BESTest - Balance Evaluation (Mini-BESTest), Timed Up and Go test (TUG) and variables from dynamic posturography.
Detailed Description
Parkinson's disease is a progressive neurodegenerative disease that affects motor functions and is characterized by bradykinesia, resting tremor, rigidity, and postural instability. Despite of pharmacological treatments, patients remain with deficits in balance, gait, autonomic system functions and cognition which impact on their quality of life.
The effects of resistance training on PD are still controversial when balance and improvement on functional tests are the targets.
Since the results of previous studies about resistance training on balance are still controversial, more interventions are required to address the question if strengthening exercise may improve or not the balance of PD patients. Our exercises will target the trunk, leg and shoulder muscles because of their contribution on patient's posture.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Resistance Training, Postural Balance, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
63 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gym Group
Arm Type
Experimental
Arm Description
With gym equipments, twice per week for 12 weeks.
Arm Title
Free Weights Group
Arm Type
Active Comparator
Arm Description
With dumbbells, elastics, twice per week for 12 weeks.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The control group will be instructed to perform stretching exercises at home in the same 12-week period, according to an illustrated booklet.
Intervention Type
Other
Intervention Name(s)
Gym Group
Intervention Description
Patients from Gym Group will perform a strengthening program of 45 minutes sessions, twice a week in a 12-week period.
The initial load is established as 60% of one-repetition maximum strength test (1RM) applied for each exercise at the beginning of program. Patients will be encouraged to perform 3 sets of 8 to 12 repetitions. All subjects will be instructed to rest for 30-60 second intervals between sets.
Intervention Type
Other
Intervention Name(s)
Free Weights Group
Intervention Description
Patients from Free Weights Group will perform a strengthening program of 45 minutes sessions, twice a week in a 12-week period. The program aim to recruit the same muscles requested in Gym Group. Investigators will apply six different exercises with patients lying supine,standing in stance, sitting and in four points kneeling. All exercises aim to strengthen abdominal muscles, trunk extensors, gluteus, quadriceps and scapula adductors. Patients will perform 3 sets of 8 to 12 repetitions, the load will be offered with dumbbells, elastics with different resistances and anklets.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
All three groups will be instructed to perform stretching exercises of trunk, leg and shoulder muscles, according to an illustrated booklet. Only the Control Group patients will be instructed to perform stretching exercises at home in the same 12-week period.
Primary Outcome Measure Information:
Title
Postural sway on Static Posturography
Description
Static Posturography is a technique used to objectively assess postural sway with patients standing still on a fixed platform that measures center of pressure displacement. Tests were standardized such as the feet position, the eye gaze and environment light, with three trials of 60-second test in eyes - open, eyes closed and eyes open in dual task condition. Investigators will analyze the anteroposterior displacement, medial-lateral displacement, area, velocity and path length.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Balance on Berg Balance Scale
Description
Berg Balance Scale is used to assess balance and falls in elderly using different tasks. It consists of 14 tasks scoring from zero to four, zero means that the patient is unable to perform the task and four means that the task is performed independently.
Time Frame
12 weeks
Title
Balance Evaluation on Mini-BESTest
Description
The Mini-BESTest contains 14 items that assess dynamic balance focusing on anticipatory postural adjustments, postural responses, sensory orientation and stability in gait. Items are scored from 0 to 2 (normal performance in balance).
Time Frame
12 weeks
Title
Functional balance and gait on Timed Up and Go test (TUG)
Description
The TUG test measures individual speed while performing the sequence: rising from a chair, walking for three meters of distance, turning around and returning to the starting position, sitting on a chair. When the examination exceeds 13 seconds, patients have higher risk of falls.
Time Frame
12 weeks
Title
Quality of life on PDQ-39 Questionnaire
Description
The PDQ-39 assess quality of life of Parkinson's disease patients over the last month. Contains 39 items and eight dimensions (Mobility, Activities of daily living, Emotional well-being, Stigma, Social support, Cognitions and Bodily discomfort).
Time Frame
12 weeks
Title
Functional balance on Dynamic Posturography
Description
Dynamic posturography is a quantitative method to assess balance. This system have sensors located below two platforms and measures vertical and horizontal forces produced by the center of gravity during a pre-determined task (sit to stand, tandem walk and step over).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 50 to 75 years old;
Hoehn and Yahr stages II or III;
Idiopathic Parkinson disease diagnosed according to the United Kingdom Parkinson's Disease Society Brain Research Centre Criteria, Institute of Neurology, London;
Ability to walk independently without walking devices aid;
Absence of orthopedic injuries or pain in joints that could interfere on training program;
Stable medication regimen for PD treatment at recruitment stage;
Mini Mental State Examination Scale (MMSE) ≥ to 27 for literate patients and schooling ≥ of 4 years of formal education;
No cardiovascular instability;
No pacemaker, decompensated metabolic disease, vestibular dysfunction, and stroke;
Availability to come to the clinic twice a week;
Not participating in other physical rehabilitation programs during and six months prior to the study.
Exclusion Criteria:
Patients will be excluded if they refuse to participate, do not sign the consent form, have a diagnosis of secondary parkinsonism or present cognitive impairment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egberto Reis Barbosa, MD, PhD
Organizational Affiliation
Department of Neurology, Clinics Hospital of University of São Paulo Faculty of Medicine, São Paulo, Brazil.
Official's Role
Study Director
Facility Information:
Facility Name
Department of Neurology of University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403010
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of Resistance Training in Parkinson Disease: A Pilot Study
We'll reach out to this number within 24 hrs