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Trial registered on ANZCTR


Registration number
ACTRN12617000121369
Ethics application status
Approved
Date submitted
12/12/2016
Date registered
23/01/2017
Date last updated
6/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of physiotherapy on selected indicators in elderly women.
Scientific title
The influence of physiotherapy on the haematological and rheological properties of blood and functional stability in elderly women.
Secondary ID [1] 290710 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
instability 301431 0
anemia 301432 0
cardiovascular disorders 301433 0
blood rheology 301434 0
blood fluidity 301435 0
Condition category
Condition code
Blood 301027 301027 0 0
Normal development and function of platelets and erythrocytes
Musculoskeletal 301028 301028 0 0
Normal musculoskeletal and cartilage development and function
Physical Medicine / Rehabilitation 301029 301029 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Rehabilitation protocols
One group will participate in the general rehabilitation exercises (GRE), and the other in dance movement therapy (DMT). Both GRE and DMT rehabilitation programs will last for 5 months (three sessions per week). In line with the motor rehabilitation guidelines for geriatric patients, each single session will last no longer than 45-50 minutes and the intensity of exercising will be corresponded to no more than 40-60% of heart rate reserve. Both GRE and DMT rehabilitation programs will be supervised by a physical therapist. Exercise sessions will group-based at the study site, at University of Physical Education in Cracow. Attendance of the sessions will be register.
The GRE program will be consisted of 5-10-minute warm-up, 30-minute endurance and balance training and 5-10-minute cool-down. Strengthening exercise training will include low-level progressive resistance exercise with light free weights, exercise ladders and exercise benches. The participants will perform 10-15 repetitions of each exercise, with a resistance corresponding to 40-60% of one-repetition maximum.
Each DMT session will be followed the same protocol. It will start with a low-intensity warm-up lasting 5-10 minutes and preparing the participants to a more strenuous exercise. The main phase of each training session will be included selected steps and figures of folk dance, ballroom dance and integration dance, as well as practicing predefined and modified choreographies, dancing-gymnastic exercises and dancing improvisation. The final phase of each training session will be lasted 5-10 minutes and included cooling-down with breathing and relaxation exercises, as well as stretching exercises aimed at optimization of the training effects.


Intervention code [1] 296602 0
Rehabilitation
Intervention code [2] 296704 0
Treatment: Other
Comparator / control treatment
Comparison outcomes between two groups (GRE group and DMT group).
Control group
Active

Outcomes
Primary outcome [1] 300450 0
The influence of the physiotherapy on the selected hematological indicators: red blood cell count, hematocrit, hemoglobin concentration, mean corpuscular hemoglobin, mean corpuscular volume, mean corpuscular hemoglobin concentration, leukocyte count and platelet count. Hematological measurements will performer using a blood analyzer (ABX Micros Hematology Analyzer,Horiba ABX Diagnostics, France).
Timepoint [1] 300450 0
Baseline and immediately following the final physiotherapy session.
Primary outcome [2] 300564 0
The influence of the physiotherapy on the selected rheological indicators: elongation index, aggregation index, the amplitude and total extent of aggregation, the half time and plasma viscosity. The elongation and aggregation of red blood cells will be determined using a Laser-assisted Optical Rotational Cell Analyzer (LORRCA, RR Mechatronics, Holland). The viscosity of plasma will determine in a viscosimeter (type D-52159 Roetgen, Myrenne, Germany).
Timepoint [2] 300564 0
Baseline and immediately following the final physiotherapy session.
Primary outcome [3] 300565 0
The influence of the physiotherapy on the selected biochemical indicators: fibrinogen, reticulocytes count, glutathione, acethylcholinesterase, glucose-6-phosphate dehydrogenase and nitric oxide. Concentration of fibrinogen will determine with an aid of Chrom-7 coagulometer. Reticulocytes will be counted in 1000 encountered erythrocytes. Level of reduced GSH, AChe and G-6-PD will be determined according to spectrophotometric method Beuther. The level of NO will be determined spectrophotometrically with a commercially available kit (Nitrate/Nitrite Calorimetric Assay Kit, catalogue no. 780001, Cayman, USA), in line with the manufacturer’s instructions.
Timepoint [3] 300565 0
Baseline and immediately following the final physiotherapy session.
Secondary outcome [1] 330007 0
The influence of the physiotherapy on functional stability (body balance), measured using a BioSway balance platform (Biodex).
Timepoint [1] 330007 0
Baseline and immediately following the final physiotherapy session.

Eligibility
Key inclusion criteria
1. Elderly women
2. Between 60 and 90 years of age.
3. Only healthy participation without e.g. paralysis and paresis interacting with independent mobility, severe vertigo, dementia, diabetes mellitus, and cardiovascular disorders.
Minimum age
60 Years
Maximum age
90 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Men
2. Women below 60 and above 90 years of age
3. Participants with paralysis and paresis interacting with independent mobility, severe vertigo, dementia, diabetes mellitus, and cardiovascular disorders.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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] 8469 0
Poland
State/province [1] 8469 0
Malopolska

Funding & Sponsors
Funding source category [1] 295138 0
University
Name [1] 295138 0
University of Physical Education
Address [1] 295138 0
al. Jana Pawla II 79
31-571 Krakow
Country [1] 295138 0
Poland
Primary sponsor type
Individual
Name
Katarzyna Filar-Mierzwa
Address
University of Physical Education
al. Jana Pawla II 78
31-571 Krakow, Poland
Country
Poland
Secondary sponsor category [1] 293959 0
None
Name [1] 293959 0
Address [1] 293959 0
Country [1] 293959 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296486 0
Boiethics Commision at the Regional Medical Chamber in Krakow
Ethics committee address [1] 296486 0
ul. Krupnicza 11a
31-123 Krakow
Ethics committee country [1] 296486 0
Poland
Date submitted for ethics approval [1] 296486 0
15/03/2014
Approval date [1] 296486 0
08/04/2014
Ethics approval number [1] 296486 0
Nr 24 /KBL/OIL/2014

Summary
Brief summary
The aim of this study will be to analyze the influence of the physiotherapy on the selected hematological and rheological indicators and body balance in older women. The research will be performed among elderly women. Research material will include about 60 participants, only women between 60 and 90 years of age. Women will be subjected to a five-month physiotherapy program (three 45-minute sessions per week). One group (30 participants) will participate in the general rehabilitation exercises (GRE), and the other (30 participants) in dance movement therapy (DMT). Before and after physiotherapy program, blood samples from all the women will be examined for:
- hematological parameters (red blood cell count, hematocrit, hemoglobin concentration, mean corpuscular hemoglobin, mean corpuscular volume, mean corpuscular hemoglobin concentration, leukocyte count and platelet count),
- rheological parameters (elongation index, aggregation index, the amplitude and total extent of aggregation, the half time, plasma viscosity),
- biochemical parameters (fibrinogen, reticulocytes count, glutathione, acethylcholinesterase, glucose-6-phosphate dehydrogenase, nitric oxide).
Subjects will be tested on the BioSway balance platform (Biodex) prior to the study and five months thereafter.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1327 1327 0 0
/AnzctrAttachments/371994-Komisja bioetyczna 1.pdf (Ethics approval)
Attachments [2] 1328 1328 0 0
/AnzctrAttachments/371994-komisja bioetyczna 2.pdf (Ethics approval)

Contacts
Principal investigator
Name 71034 0
Dr Katarzyna Filar-Mierzwa
Address 71034 0
University of Physical Education
Department of Occupational Therapy
al. Jana Pawla II 78
31-571 Krakow
Country 71034 0
Poland
Phone 71034 0
+48126831102
Fax 71034 0
Email 71034 0
katarzyna.filar@awf.krakow.pl
Contact person for public queries
Name 71035 0
Dr Katarzyna Filar-Mierzwa
Address 71035 0
University of Physical Education
Department of Occupational Therapy
al. Jana Pawla II 78
31-571 Krakow
Country 71035 0
Poland
Phone 71035 0
+48126831102
Fax 71035 0
Email 71035 0
katarzyna.filar@awf.krakow.pl
Contact person for scientific queries
Name 71036 0
Dr Katarzyna Filar-Mierzwa
Address 71036 0
University of Physical Education
Department of Occupational Therapy
al. Jana Pawla II 78
31-571 Krakow
Country 71036 0
Poland
Phone 71036 0
+48126831102
Fax 71036 0
Email 71036 0
katarzyna.filar@awf.krakow.pl

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary