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Trial registered on ANZCTR


Registration number
ACTRN12619001718134
Ethics application status
Approved
Date submitted
10/11/2019
Date registered
5/12/2019
Date last updated
5/12/2019
Date data sharing statement initially provided
5/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of water-based exercises on balance, functional status, fatigue and quality of life among patients with multiple sclerosis: case series.
Scientific title
Effects of exercises in water in patients with multiple sclerosis.
Secondary ID [1] 299773 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple sclerosis 315138 0
functional status 315139 0
quality of life 315140 0
Condition category
Condition code
Neurological 313457 313457 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will participate in 6-week hydrotherapy programme 2 times a week. Each session will last for approximately 45 minutes. Hydrotherapy (warm-up, Ai-Chi exercises, cool down) will take place in a swimming pool which is 1.20 meters deep with a water temperature: 30-31 degrees Celsius. Each session will start with a 10 minute warm-up, which will include dynamic, active exercises, some with use of pool noodles, kickboards or balls. The main part, Ai-Chi exercises, will last for 25 minutes. Ai-Chi consists of 16 exercises performed in standing position, accompanied by deep breathing. The patient should be submersed to shoulder-depth level with a slight flexed knees. The Ai-Chi exercises will be performed with specified order and pace: upper limbs, upper limbs and torso, upper and lower limbs and torso. During exercise programme, the support plane for the lower extremities gradually decreases. There will be a progression of Ai-Chi exercises with each session (including more demanding exercises, increasing number of repetitions). Ai-Chi exercises will be performed by physiotherapist, experienced in neurophysiotherapy and water therapies. For better visibility the physiotherapist will stand outside the pool. There will be trained assistants inside to pool to support patients with poor balance. Each session will end with 10 minutes of cool down exercises, which will include stretching and free walking. There will be an attendance list to monitor patients adherence to intervention.
Intervention code [1] 316028 0
Rehabilitation
Intervention code [2] 316029 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321926 0
Functional status (patient's mobility assessed by The Timed Up and Go test )
Timepoint [1] 321926 0
baseline and 6 weeks after commencement of intervention
Primary outcome [2] 321927 0
Functional status (lower body strength, assessed by 30 s Chair Stand from Senior Fitness Test)
Timepoint [2] 321927 0
baseline and 6 weeks after commencement of intervention
Primary outcome [3] 321928 0
Fatigue (assessed by Fatigue Severity Scale and sEMG)
Timepoint [3] 321928 0
baseline and 6 weeks after commencement of intervention
Secondary outcome [1] 376722 0
Balance (assessed by Short Physical Performannce Battery, balance platform)
Timepoint [1] 376722 0
baseline and 6 weeks after commencement of intervention
Secondary outcome [2] 376723 0
Pain (VAS scale 0-10)
Timepoint [2] 376723 0
baseline and 12 weeks after commencement of intervention
Secondary outcome [3] 376724 0
Quality of life (Ferrans and Powers Quality of Life Index ()
Timepoint [3] 376724 0
baseline and 6 weeks after commencement of intervention

Eligibility
Key inclusion criteria
- Patients diagnosed with Multiple sclerosis
- No systemic contraindications to undertake the proposed forms of exercise
- Written consent to participate in a clinical trial
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- systemic contraindications to undertake the proposed forms of exercise

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22040 0
Poland
State/province [1] 22040 0
lubuskie

Funding & Sponsors
Funding source category [1] 304237 0
Charities/Societies/Foundations
Name [1] 304237 0
Towarzystwo Walki z Kalectwem Oddzial w Gorzowie Wlkp.
Address [1] 304237 0
ul. Kosynierow Gdynskich 81
66-400 Gorzow Wlkp.
Country [1] 304237 0
Poland
Funding source category [2] 304238 0
University
Name [2] 304238 0
Poznan University of Physical Education in Gorzow Wlkp.
Address [2] 304238 0
ul. Estkowskiego 13
66-400 Gorzow Wlkp.
Country [2] 304238 0
Poland
Primary sponsor type
University
Name
Poznan University School of Physical Education, Gorzow Wielkopolski
Address
Poznan University School of Physical Education, Gorzow Wielkopolski, ul. Eskowskiego 13, 66-400 Gorzow Wielkopolski
Country
Poland
Secondary sponsor category [1] 304477 0
None
Name [1] 304477 0
Address [1] 304477 0
Country [1] 304477 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304697 0
Bioethics committee - Poznan University of Medical Sciences
Ethics committee address [1] 304697 0
Komisja Bioetyczna przy Uniwersytecie Medycznym im. Karola Marcinkowskiego w Poznaniu, ul. Bukowska 70, pok A204, 60-812 Poznan
Ethics committee country [1] 304697 0
Poland
Date submitted for ethics approval [1] 304697 0
Approval date [1] 304697 0
16/06/2016
Ethics approval number [1] 304697 0
675/16

Summary
Brief summary
The goal of the study is to assess and compare changes in functional status, fatigue, pain level, quality of life in patients with multiple sclerosis. Patients will participate in 6-week hydrotherapy programme 2 times a week. Each session will last for approximately 45 minutes and will include warm-up, Ai-Chi exercises and cool down.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97906 0
Dr Anita Kulik
Address 97906 0
Zamiejscowy Wydzial Kultury Fizycznej
ul. Orlat Lwowskich 4-6 66-400 Gorzow Wielkopolski
Country 97906 0
Poland
Phone 97906 0
+48957279222
Fax 97906 0
Email 97906 0
a.kulik@awf-gorzow.edu.pl
Contact person for public queries
Name 97907 0
Dr Anita Kulik
Address 97907 0
Zamiejscowy Wydzial Kultury Fizycznej
ul. Orlat Lwowskich 4-6 66-400 Gorzow Wielkopolski
Country 97907 0
Poland
Phone 97907 0
+48957279222
Fax 97907 0
Email 97907 0
a.kulik@awf-gorzow.edu.pl
Contact person for scientific queries
Name 97908 0
Dr Anita Kulik
Address 97908 0
Zamiejscowy Wydzial Kultury Fizycznej
ul. Orlat Lwowskich 4-6 66-400 Gorzow Wielkopolski
Country 97908 0
Poland
Phone 97908 0
+48957279222
Fax 97908 0
Email 97908 0
a.kulik@awf-gorzow.edu.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results