Protocol summary
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Study aim
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Comparing the Effect of Twelve weeks Pilates and Aquatic Training on Balance, Muscle strength and Range of Motion in Patients with Parkinson's Disease
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Design
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This research is semi-experimental and applied. Among the male patients referred to AlZahra Isfahan Hospital, 50 people were selected as a sample and divided into three groups of Pilates, water exercise and control in a non-random manner.
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Settings and conduct
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Isfahan University
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Participants/Inclusion and exclusion criteria
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1. Absence of cardiovascular diseases
2. Not suffering from mental illnesses
3. No history of metabolic diseases
4. Age range 35-75 years
5. No history of orthopedic diseases
6. Not participating in regular sports activities in the two months before the study
7. All the subjects had passed at least one year since the diagnosis of their disease.
8. The gender variable was controlled (all subjects of the research were men).
9. Subjects were selected from AlZahra Hospital, Isfahan.
10. The subjects were in stage 2 and 3 of Hun and Yahr scale.
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Intervention groups
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1. Pilates
2. Aquatic training
3. Control
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Main outcome variables
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Balance
Muscle strength
Range of motion
General information
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Reason for update
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Adding the rest of the measured factors and other information needed to complete the study information
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2015120825436N1
Registration date:
2015-12-30, 1394/10/09
Registration timing:
retrospective
Last update:
2023-05-09, 1402/02/19
Update count:
1
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Registration date
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2015-12-30, 1394/10/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice Chancellor for research of Isfahan University
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Expected recruitment start date
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2012-03-19, 1390/12/29
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Expected recruitment end date
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2013-03-20, 1391/12/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing the effect of 12 weeks of Pilates and Aquatic training on balance, muscle strength and range of motion in patients with Parkinson's disease
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Public title
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Comparing the effect of Pilates and Aquatic training in treatment of Parkinson's disease
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Purpose
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Other
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Inclusion/Exclusion criteria
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Inclusion criteria:
Based on the neurologist's diagnosis, the patients have mild to moderate Parkinson's disease (stage 1 to 3). No diagnosis of musculoskeletal problems is evident. No defects are observed in the organs. No cardiovascular disease or acute illness has been reported and they are not undergoing physical therapy, but they have the ability and willingness to do Pilates and hydrotherapy exercises.
Exclusion criteria:
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Age
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No age limit
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Gender
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Male
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-11-23, 1401/09/02
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Ethics committee reference number
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IR.UI.REC.1401.109
Health conditions studied
1
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Description of health condition studied
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Parkinson's disease
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ICD-10 code
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G30, G31,
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ICD-10 code description
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Other degenerative diseases of the nervous system
Primary outcomes
1
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Description
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balance
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Timepoint
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before intervention-three months after the intervention
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Method of measurement
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Berg Balance Scale
2
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Description
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Muscle strength
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Timepoint
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before intervention-three months after the intervention
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Method of measurement
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Isokinetic Biodex system (3)
3
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Description
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Range of motion
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Timepoint
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before intervention-three months after the intervention
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Method of measurement
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Isokinetic Biodex system (3)
Intervention groups
1
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Description
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Intervention group: for 12 weeks took part in 3 sessions (each 60 minutes) of Aquatic training and Pilates, as well as taking medication
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Category
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Rehabilitation
2
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Description
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Control group: medication
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice Chancellor for research of Isfahan University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available