History
# Registration date Revision Id
2 2023-04-12, 1402/01/23 264220
1 2015-12-30, 1394/10/09 21274
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  • Protocol summary

    Objectives: to assess the effect of hydrotherapy program on balance in patients with Parkinson's disease Design: semi-experimental pretest-posttest with control group Setting and Conduct: 36 men patients with Parkinson's were selected and voluntarily entered in two groups of experimental (n=20) and control (n =16). Major inclusion and exclusion criteria: patients consent for volunteer participation in the study, patients who were diagnosed of mild to moderate stages (I- III) by neurologist, willingness and ability to exercise, lack of muscular-skeletal problems, lack of maim, lack of cardiovascular or serious diseases and no involvement in any exercise activity or physiotherapy treatments. Exclusion criteria: inability to perform hydrotherapy, being in advanced stages of the disease (IV&V) according to Hoehn & Yahr scale. Interventions: experimental group, for 12 weeks took part in 3 sessions (each 60 minutes) of hydrotherapy, as well as taking medications. The control group only took medications, receiving no regular exercise program. Main outcome measures: balance
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    اهداف: بررسی تاثیر یک دوره آب درمانی بر تعادل بیماران مبتلا به پارکینسون طراحی: نيمه تجربي و پیش آزمون-پس آزمون با گروه کنترل نحوه انجام: 36 مرد مبتلا به پارکینسون بصورت در دسترس انتخاب و سپس بصورت داوطلبانه در دو گروه تجربی (20 نفر) و کنترل (16نفر) قرار خواهند گرفت. شرایط ورود: کسب رضایت نامه از بیمار جهت شرکت داوطلبانه؛ قرار داشتن در مراحل خفیف تا متوسط (I- III) بیماری طبق تشخیص متخصص مغز و اعصاب؛ تمایل و توانایی انجام ورزش؛ عدم ابتلا به مشكلات عضلاني-استخواني؛ نقص عضو؛ بيماري‌هاي قلبي- عروقي يا بيماري‌هاي حاد؛ عدم انجام فعالیت ورزشی یا درمان فیزیوتراپی شرایط خروج: ناتوانی در انجام تمرینات آب درمانی؛ قرار داشتن در مراحل پیشرفته تر بیماری (IV&V) بر اساس مقیاس Hoehn &Yahr مداخلات: گروه تجربي علاوه بر درمان دارويي، به مدت 12 هفته، سه جلسه ‌60 دقیقه ای در تمرينات آب درمانی منتخب شرکت می کنند، در حالیکه گروه کنترل فقط تحت درمان دارویی هستند و هیچ برنامه ورزشی منظمی دریافت نخواهند کرد. متغیرهای پیامد اصلی: تعادل
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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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    مقایسه تاثیر دوازده هفته تمرینات پیلاتس و آب بر تعادل، قدرت عضلانی و دامنه حرکتی بیماران پارکینسون
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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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    این پژوهش از نوع نیمه تجربی و کاربردی است. از میان بیماران مرد مراجعه کننده به بیمارستان الزهراءاصفهان، 50نفر بعنوان نمونه انتخاب و بصورت غیرتصادفی به سه گروه پیلاتس، ورزش در آب و کنترل تقسیم شدند.
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    Isfahan University
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    دانشگاه اصفهان
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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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    1. عدم ابتلا به بیماریهای قلبی- عروقی 2. عدم ابتلا به بیماریهای روانی 3. عدم سابقه بیماریهای متابولیکی 4. دامنه سنی 75-35 سال 5. عدم سابقه بیماریهای ارتوپدیک 6. عدم شرکت در فعالیت ورزشی منظم در دو ماه قبل از مطالعه 7. کلیه آزمودنیها حداقل یک سال از زمان تشخیص بیماری آنها گذشته بود. 8. متغیر جنس کنترل شده بود (کلیه آزمودنیهای پژوهش را مردان تشکیل میدادند). 9. آزمودنیها از بیمارستان الزهراء اصفهان انتخاب شدند. 10 . آزمودنیها در مرحله 2و 3 مقیاس هون و یار قرار داشتند .
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    1. Pilates 2. Aquatic training 3. Control
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    1. پیلاتس 2. آب درمانی 3. کنترل
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    Balance Muscle strength Range of motion
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    تعادل قدرت عضلانی دامنه حرکتی
  • General information

    36
    50
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    Adding the rest of the measured factors and other information needed to complete the study information
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    اضافه نمودن بقیه فاکتورهای اندازه گیری شده و سایر اطلاعات مورد نیاز جهت کامل شدن اطلاعات مطالعه
    The effect of hydrotherapy in treatment of Parkinson's disease
    Comparing the effect of Pilates and Aquatic training in treatment of Parkinson's disease
    تاثیر آب درمانی بر درمان پارکینسون
    مقایسه تاثیر پیلاتس و آب درمانی در درمان پارکینسون
    Clinical trial the effect of hydrotherapy on balance in patients with Parkinson's disease
    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
    کارآزمایی بالینی تاثیر آب درمانی بر تعادل بیماران مبتلا به پارکینسون
    مقایسه تاثیر 12 هفته پیلاتس و آب درمانی بر تعادل، قدرت عضلانی و دامنه حرکتی بیماران مبتلا به پارکینسون
    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.
    بر اساس تشخیص متخصص مغز و اعصاب، بیماران مبتلا به بیماری درجه خفیف تا متوسط پارکینسون (مرحله ۱ تا ۳) هستند. هیچ تشخیصی از مشکلات اسکلتی_عضلانی مشهود نیست. هیچ نقصی در اندام ها مشاهده نمی شود. هیچ بیماری قلبی و عروقی یا بیماری حاد گزارش نشده است و تحت فیزیوتراپی نیستند، اما توانایی و تمایل انجام تمرینات پیلاتس و آب درمانی را دارند.
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  • Secondary Ids

    #1
    -
    empty
    -
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  • Ethics committees

    #1
    2013-01-18, 1391/10/29
    2022-11-23, 1401/09/02
    -
    IR.UI.REC.1401.109
  • Primary outcomes

    #1
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    Muscle strength
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    قدرت عضلانی
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    before intervention-three months after the intervention
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    قبل از مداخله و سه ماه بعد از شروع مداخله
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    Isokinetic Biodex system (3)
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    سیستم بایودکس ایزوکینتیک (3)
    #2
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    Range of motion
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    دامنه حرکتی
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    before intervention-three months after the intervention
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    قبل از مداخله و سه ماه بعد از شروع مداخله
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    Isokinetic Biodex system (3)
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    سیستم بایودکس ایزوکینتیک (3)
  • Secondary outcomes

    #1
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  • Intervention groups

    #1
    Intervention group: for 12 weeks took part in 3 sessions (each 60 minutes) of hydrotherapy, as well as taking medication
    Intervention group: for 12 weeks took part in 3 sessions (each 60 minutes) of Aquatic training and Pilates, as well as taking medication
    گروه مداخله: درمان دارويي و مداخله آب درمانی به مدت 12 هفته، سه جلسه در هفته، هر جلسه یک ساعت
    گروه مداخله: درمان دارويي و مداخله آب درمانی و پیلاتس به مدت 12 هفته، سه جلسه در هفته، هر جلسه یک ساعت
  • Recruitment centers

    #1
    Name of recruitment center - English: Alzahra Hospital
    Name of recruitment center - Persian: بیمارستان الزهرا
    Full name of responsible person - English: Dr Ahmad Chitsaz
    Full name of responsible person - Persian: دکتر احمد چیت ساز
    Street address - English: Alzahra Hospital, Sofeh Boulevard, Shahid Keshvari Highway, Isfahan
    Street address - Persian: اصفهان، بزرگراه شهید کشوری، بلوار صفه، بیمارستان الزهرا
    City - English: Isfahan
    City - Persian: اصفهان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Alzahra Hospital
    Name of recruitment center - Persian: بیمارستان الزهرا
    Full name of responsible person - English: Dr Ahmad Chitsaz
    Full name of responsible person - Persian: دکتر احمد چیت ساز
    Street address - English: Alzahra Hospital, Sofeh Boulevard, Shahid Keshvari Highway, Isfahan
    Street address - Persian: اصفهان، بزرگراه شهید کشوری، بلوار صفه، بیمارستان الزهرا
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 887191677
    Phone: +98 913 979 4823
    Fax:
    Email: hakimehbaziyar@yahoo.com
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice Chancellor for research of Isfahan University
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه اصفهان
    Full name of responsible person - English: Dr Mehdi Kargarfard
    Full name of responsible person - Persian: دکتر مهدی کارگرفرد
    Street address - English: Faculty of Physical Education, Isfahan University
    Street address - Persian: دانشگاه اصفهان، دانشکده تربیت بدنی
    City - English: Isfahan
    City - Persian: اصفهان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Vice Chancellor for research of Isfahan University
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه اصفهان
    Full name of responsible person - English: Dr Mehdi Kargarfard
    Full name of responsible person - Persian: دکتر مهدی کارگرفرد
    Street address - English: Faculty of Physical Education, Isfahan University
    Street address - Persian: دانشگاه اصفهان، دانشکده تربیت بدنی
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 887191677
    Phone: +98 913 979 4823
    Fax:
    Email: hakimehbaziyar@yahoo.com
    Web page address:
    empty
    Public
    empty
    Domestic
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    Academic
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: -
    Name of organization / entity - Persian: -
    Full name of responsible person - English: Hakimeh Baziyar
    Full name of responsible person - Persian: حکیمه بازیار
    Position - English: MS of Exercise Physiology
    Position - Persian: کارشناس ارشد فیزیولوژی ورزشی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No. 17, 27 Street, Bouali Boulevard, Borujen
    Street address - Persian: بروجن، بلوار بوعلی، کوچه 27، پلاک17
    City - English: Borujen
    City - Persian: بروجن
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 38 3422 7674
    Mobile: +98 913 979 4823
    Fax:
    Email: Hakimehbaziyar@yahoo.com; Hakimehbaziyar@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: دانشگاه اصفهان
    Name of organization / entity - Persian: Isfahan University
    Full name of responsible person - English: Hakimeh Baziyar
    Full name of responsible person - Persian: حکیمه بازیار
    Position - English: PhD student of Exercise Physiology
    Position - Persian: دکتری فیزیولوژی ورزشی
    Latest degree: master
    Area of specialty/work: 69
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No. 17, 27 Street, Bouali Boulevard, Borujen
    Street address - Persian: بروجن، بلوار بوعلی، کوچه 27، پلاک17
    City - English: Boroujen
    City - Persian: بروجن
    Province: Chahar-Mahal-va-Bakhtiari
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 887116797
    Phone: +98 38 3422 7674
    Mobile: +98 913 979 4823
    Fax:
    Email: Hakimehbaziyar@yahoo.com
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: -
    Name of organization / entity - Persian: -
    Full name of responsible person - English: Hakimeh Baziyar
    Full name of responsible person - Persian: حکیمه بازیار
    Position - English: Ms of Exercise Physiology
    Position - Persian: کارشناس ارشد فیزیولوژی ورزشی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No. 17, 27 Street, Bouali Boulevard, Borujen
    Street address - Persian: بروجن، بلوار بوعلی، کوچه27، پلاک17
    City - English: Borujen
    City - Persian: بروجن
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 913 979 4823
    Mobile: +98 913 979 4823
    Fax:
    Email: Hakimehbaziyar@yahoo.com; Hakimehbaziyar@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Isfahan Uni
    Name of organization / entity - Persian: دانشگاه اصفهان
    Full name of responsible person - English: Hakimeh Baziyar
    Full name of responsible person - Persian: حکیمه بازیار
    Position - English: PhD of Exercise Physiology
    Position - Persian: دکتری فیزیولوژی ورزشی
    Latest degree: master
    Area of specialty/work: 69
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No. 17, 27 Street, Bouali Boulevard, Borujen
    Street address - Persian: بروجن، بلوار بوعلی، کوچه27، پلاک17
    City - English: Boroujen
    City - Persian: بروجن
    Province: Chahar-Mahal-va-Bakhtiari
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 887116797
    Phone: +98 913 979 4823
    Mobile: +98 913 979 4823
    Fax:
    Email: Hakimehbaziyar@yahoo.com
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hakimeh Baziyar
    Full name of responsible person - Persian: حکیمه بازیار
    Position - English: Ms of exercise physiology
    Position - Persian:
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English:
    Street address - Persian:
    City - English: Boroojen
    City - Persian: بروجن
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 38 3422 7674
    Mobile: +98 913 979 4823
    Fax:
    Email: Hakimehbaziyar@yahoo.com; Hakimehbaziyar@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Isfahan Uni
    Name of organization / entity - Persian: دانشگاه اصفهان
    Full name of responsible person - English: Hakimeh Baziyar
    Full name of responsible person - Persian: حکیمه بازیار
    Position - English: PhD of exercise physiology
    Position - Persian: دکتری
    Latest degree: master
    Area of specialty/work: 69
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Borujen - Buali Boulevard - Bagheral Uloom Alley - Plate 17
    Street address - Persian: بروجن -بلوار بوعلی-کوچه باقرالعلوم-پلاک۱۷
    City - English: Boroujen
    City - Persian: بروجن
    Province: Chahar-Mahal-va-Bakhtiari
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 887191677
    Phone: +98 38 3422 7674
    Mobile: +98 913 979 4823
    Fax:
    Email: Hakimehbaziyar@yahoo.com
    Web page address:
  • Sharing plan

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    no
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    There is no further information
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    اطلاعات بیشتری وجود ندارد

Protocol summary

Study aim
Comparing the Effect of Twelve weeks Pilates and Aquatic Training on Balance, Muscle strength and Range of Motion in Patients with Parkinson's Disease
Design
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.
Settings and conduct
Isfahan University
Participants/Inclusion and exclusion criteria
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.
Intervention groups
1. Pilates 2. Aquatic training 3. Control
Main outcome variables
Balance Muscle strength Range of motion

General information

Reason for update
Adding the rest of the measured factors and other information needed to complete the study information
Acronym
IRCT registration information
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
Registration date
2015-12-30, 1394/10/09
Registrant information
Name
Hakimeh Baziyar
Name of organization / entity
-
Country
Iran (Islamic Republic of)
Phone
+98 38 3422 7674
Email address
hakimehbaziyar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Isfahan University
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
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Actual recruitment end date
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Trial completion date
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Scientific title
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
Public title
Comparing the effect of Pilates and Aquatic training in treatment of Parkinson's disease
Purpose
Other
Inclusion/Exclusion criteria
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:
Age
No age limit
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University
Street address
Isfahan University, Hezaar Jerib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8871916797
Approval date
2022-11-23, 1401/09/02
Ethics committee reference number
IR.UI.REC.1401.109

Health conditions studied

1

Description of health condition studied
Parkinson's disease
ICD-10 code
G30, G31,
ICD-10 code description
Other degenerative diseases of the nervous system

Primary outcomes

1

Description
balance
Timepoint
before intervention-three months after the intervention
Method of measurement
Berg Balance Scale

2

Description
Muscle strength
Timepoint
before intervention-three months after the intervention
Method of measurement
Isokinetic Biodex system (3)

3

Description
Range of motion
Timepoint
before intervention-three months after the intervention
Method of measurement
Isokinetic Biodex system (3)

Secondary outcomes

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Intervention groups

1

Description
Intervention group: for 12 weeks took part in 3 sessions (each 60 minutes) of Aquatic training and Pilates, as well as taking medication
Category
Rehabilitation

2

Description
Control group: medication
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr Ahmad Chitsaz
Street address
Alzahra Hospital, Sofeh Boulevard, Shahid Keshvari Highway, Isfahan
City
Isfahan
Province
Isfehan
Postal code
887191677
Phone
+98 913 979 4823
Email
hakimehbaziyar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University
Full name of responsible person
Dr Mehdi Kargarfard
Street address
Faculty of Physical Education, Isfahan University
City
Isfahan
Province
Isfehan
Postal code
887191677
Phone
+98 913 979 4823
Email
hakimehbaziyar@yahoo.com
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Isfahan University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
دانشگاه اصفهان
Full name of responsible person
Hakimeh Baziyar
Position
PhD student of Exercise Physiology
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 17, 27 Street, Bouali Boulevard, Borujen
City
Boroujen
Province
Chahar-Mahal-va-Bakhtiari
Postal code
887116797
Phone
+98 38 3422 7674
Fax
Email
Hakimehbaziyar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan Uni
Full name of responsible person
Hakimeh Baziyar
Position
PhD of Exercise Physiology
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 17, 27 Street, Bouali Boulevard, Borujen
City
Boroujen
Province
Chahar-Mahal-va-Bakhtiari
Postal code
887116797
Phone
+98 913 979 4823
Fax
Email
Hakimehbaziyar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan Uni
Full name of responsible person
Hakimeh Baziyar
Position
PhD of exercise physiology
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Borujen - Buali Boulevard - Bagheral Uloom Alley - Plate 17
City
Boroujen
Province
Chahar-Mahal-va-Bakhtiari
Postal code
887191677
Phone
+98 38 3422 7674
Fax
Email
Hakimehbaziyar@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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