Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002017202
Ethics application status
Approved
Date submitted
10/12/2018
Date registered
17/12/2018
Date last updated
15/06/2021
Date data sharing statement initially provided
17/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Aquatic exercise training in the process of rehabilitation in patients after breast cancer treatment
Scientific title
Aquatic exercise training and relationship between sagittal spinal curves and isokinetic trunk muscle endurance in women after breast cancer treatment
Secondary ID [1] 296837 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 310746 0
Condition category
Condition code
Physical Medicine / Rehabilitation 309437 309437 0 0
Physiotherapy
Cancer 309438 309438 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients were qualified by the physician responsible for the course and interpretation of the test results. Prior to the implementation of the experiment, all subjects were informed about its purpose, manner of conducting and the possibility of resignation at any time during the research project. The respondents gave written consent to participate in the research. In addition, there was an information meeting on the impact of the effects of various forms of physical activity on the function of the trunk flexors and extensors, and body posture in sagittal plane.
The subjects were divided into two groups:
group I: women subjected to the aquatic exercise training.
group II: patients subjected to the general improving exercise, which is the standard after a breast cancer treatment in Poland.
8-week aquatic exercise training and general fitness exercise were conducted. Each of the exercise programs were administered by physiotherapist. The exercise regimens were implemented on the basis of similar organization of individual training units. Each training unit within different exercise regimens involved preliminary and final stages (equivalent across the regimens both in terms of duration and selection of activity types) and the main stage (specific to each particular regimen).
Aquatic exercise training and general fitness exercise comprised free active exercising (performed independently by the patient, without the help of a physiotherapist or specialized equipment) of the upper and lower extremities (e.g squat, lunge), and activities strengthening the muscles of the back (e.g wall sits, back extensions) and abdomen (e.g partial crunches, knee to chest,), complemented by balance and coordination exercises (e.g single leg squat, balance walk).
The water exercise plan was additionally provided with walking forwards and backwards in the water. Physical exercises in the two study groups were pursued for eight weeks at a frequency of two 45-minute training sessions a week.
The basic parameter defining the intensity of physical exercise was the pulse limit. With an aid of Polar pulse meters (RS 300 × G1 model), cardiac rhythm monitoring was combined
with temporal options by setting a pulse range within which physical exercise was performed. The intensity of exercise oscillated around 70–75% of the maximum pulse rate determined individually for each study patient using the formula: 220 – age.
Exercise intensity was adjusted by gradually reducing the number of resting intervals and increasing the number of repetitions in exercise series or the distance covered.
The number of restitution intervals consisting of upper extremity relaxation and respiratory exercise was reduced every other week, beginning with five intervals (weeks 1–2) and ending with two (weeks 7–8). During the same period, the number of exercise repetitions in series was increased from 10 (weeks 1–2) to 16 (weeks 7–8) in the two study groups.

Intervention code [1] 313120 0
Rehabilitation
Comparator / control treatment
Group II was a control group (people from this group had implemented general improving exercise, which is the standard after a breast cancer treatment in Poland).
Control group
Active

Outcomes
Primary outcome [1] 308391 0
Assesment of inclination of the lumbosacral section (alpha angle) via Computer Body Posture Diagnosis device (USB version with the CQ-PostureUSB for Windows XP software).
Timepoint [1] 308391 0
Baseline and after 8 weeks.
Primary outcome [2] 308392 0
Assesment of inclination of the thoracolumbar section (beta angle) via Computer Body Posture Diagnosis device (USB version with the CQ-PostureUSB for Windows XP software).
Timepoint [2] 308392 0
Baseline and after 8 weeks.
Primary outcome [3] 308393 0
Assesment of inclination of the upper thoracic section (gamma angle) via Computer Body Posture Diagnosis device (USB version with the CQ-PostureUSB for Windows XP software).
Timepoint [3] 308393 0
Baseline and after 8 weeks.
Secondary outcome [1] 354846 0
Assessment of trunk extensors endurance measures was tested with the Biodex Multi-Joint 3 Isokinetic Dynamometer. Parameter: Total Work (TW).
Timepoint [1] 354846 0
Baseline and after 8 weeks
Secondary outcome [2] 354847 0
Assessment of trunk flexors endurance measures was tested with the Biodex Multi-Joint 3 Isokinetic Dynamometer. Parameter: Total Work (TW).
Timepoint [2] 354847 0
Baseline and after 8 weeks
Secondary outcome [3] 354848 0
Assessment of trunk extensors endurance measures was tested with the Biodex Multi-Joint 3 Isokinetic Dynamometer. Parameter: Average Power (AP).
Timepoint [3] 354848 0
Baseline and after 8 weeks
Secondary outcome [4] 354849 0
Assessment of trunk flexors endurance measures was tested with the Biodex Multi-Joint 3 Isokinetic Dynamometer. Parameter: . Average Power (AP).
Timepoint [4] 354849 0
Baseline and after 8 weeks

Eligibility
Key inclusion criteria
-Women treated due to breast cancer (with the radical or saving procedure);
-Period of over one year after the treatment;
-No illness remission during the past year;
-Lymphedema within the upper extremity of up to 2 cm;
-Signed consent for participation in the study and exercise program.
Minimum age
50 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
-Mental state not allowing communication with the participant;
– Osteoarticular, circulatory, respiratory, and/or nervous system injury or dysfunction limiting motor skills.

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)
Allocation was concealed via sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/03/2018
Date of last participant enrolment
Anticipated
Actual
13/04/2018
Date of last data collection
Anticipated
Actual
8/06/2018
Sample size
Target
60
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 21115 0
Poland
State/province [1] 21115 0

Funding & Sponsors
Funding source category [1] 301412 0
University
Name [1] 301412 0
University School of Physical Education in Wroclaw
Country [1] 301412 0
Poland
Primary sponsor type
Individual
Name
Justyna Hanuszkiewicz
Address
Justyna Hanuszkiewicz, PhD
Department of Physiotherapy in Internal Diseases
University School of Physical Education in Wroclaw, Poland
al.Ignacego Jana Paderewskiego 35
51-612 Wroclaw,
Country
Poland
Secondary sponsor category [1] 301088 0
None
Name [1] 301088 0
Address [1] 301088 0
Country [1] 301088 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302146 0
Senacka Komisja ds. Etyki Badan Naukowych przy Akademii Wychowania Fizycznego we Wroclawiu
Ethics committee address [1] 302146 0
Ethics committee country [1] 302146 0
Poland
Date submitted for ethics approval [1] 302146 0
06/02/2018
Approval date [1] 302146 0
08/03/2018
Ethics approval number [1] 302146 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89278 0
Dr Justyna Hanuszkiewicz
Address 89278 0
Justyna Hanuszkiewicz, PhD University School of Physical Education al. Ignacego Jana Paderewskiego 35 51-612 Wroclaw, Poland
Country 89278 0
Poland
Phone 89278 0
+48713473520
Fax 89278 0
Email 89278 0
[email protected]
Contact person for public queries
Name 89279 0
Justyna Hanuszkiewicz
Address 89279 0
Justyna Hanuszkiewicz, PhD University School of Physical Education al. Ignacego Jana Paderewskiego 35 51-612 Wroclaw, Poland
Country 89279 0
Poland
Phone 89279 0
+48713473520
Fax 89279 0
Email 89279 0
[email protected]
Contact person for scientific queries
Name 89280 0
Justyna Hanuszkiewicz
Address 89280 0
Justyna Hanuszkiewicz, PhD University School of Physical Education al. Ignacego Jana Paderewskiego 35 51-612 Wroclaw, Poland
Country 89280 0
Poland
Phone 89280 0
+48713473520
Fax 89280 0
Email 89280 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Only researchers who provide a methodologically sound proposal.

Conditions for requesting access:
• -

What individual participant data might be shared?
• individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• For IPD meta-analyses.

When can requests for individual participant data be made (start and end dates)?
From:
Immediately after the publication of the material in the journal. End-date of availability: 6 months from publication.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Requirement to sign data access agreement

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
685Ethical approval    Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.