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Trial registered on ANZCTR


Registration number
ACTRN12620000425998
Ethics application status
Approved
Date submitted
7/02/2020
Date registered
30/03/2020
Date last updated
30/03/2020
Date data sharing statement initially provided
30/03/2020
Date results information initially provided
30/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nordic walking in the process of rehabilitation in patients after breast cancer treatment
Scientific title
The effect of Nordic walking on the isokinetic trunk muscle endurance and sagittal spinal curvatures in women after breast cancer treatment– related age.
Secondary ID [1] 300423 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 316081 0
Condition category
Condition code
Cancer 314359 314359 0 0
Breast
Physical Medicine / Rehabilitation 314360 314360 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To participate in the study, patients were qualified by a physiotherapist under the supervision of a physician. 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 Nordic walking 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 Nordic walking.
group II: patients subjected to the general exercise programme, which is the standard after a breast cancer treatment in Poland.
Additionally, both groups divided into age subgroup: middle-aged (45-59 years old) and older (60-75 years old) breast cancer survivors.
The 8-week Nordic walking and the standard general exercise trainings were conducted. The exercise programs consisted of 45-min sessions, performed two times per week over 8 weeks under the supervision of a Nordic walking instructor (in group I) or a physiotherapist (in group II).Exercise programmes were organised as individual training units that were similar. The initial (5-min) and final (5-min) parts of every unit were divided equally in terms of duration and types of exercises applied (stretching and breathing exercises).
The main part of Nordic walking (40-min) aimed at learning and improving walking technique with the use of special poles. The main part of the standard general exercise (40-min) 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).
During 45–50% of each 45-min exercise session, the training intensity was kept below 70% of the participant’s maximum heart rate, calculated according to the formula: pulse 220 – age = maximum function. Polar pulsometers (RS 300 × G1 model) monitored the participant’s heart rate at least twice during each training unit and the exercise intensity was found to be within the desired limits. The intensity of training interventions in the both the groups was increased by gradually reducing the number of rest breaks. The number of rest breaks, including upper limb relaxation and respiratory exercises, was reduced every second week from five breaks (weeks 1–2) to two breaks (weeks 7–8). At the same time, the distance covered in the Nordic walking group was increased from 2400 m (weeks 1–2) to 3600 m (weeks 7–8). For the standard general exercise training group, the number of repetitions for each set of exercises was increased from 10 (weeks 1–2) to 16 repetitions (weeks 7–8).

Intervention code [1] 316722 0
Rehabilitation
Intervention code [2] 317052 0
Treatment: Other
Comparator / control treatment
Group II was a control group (women from this group had implemented a general improving exercise, which is the standard after a breast cancer treatment in Poland). The group divided into age subgroup: middle-aged (45-59 years old) and older (60-75 years old) breast cancer survivors.
Control group
Active

Outcomes
Primary outcome [1] 322724 0
Assesment of inclination angle of trunk (KPT) via Computer Body Posture Diagnosis device (USB version with the CQ-PostureUSB for Windows XP software).
Timepoint [1] 322724 0
Baseline and after 8 weeks.
Primary outcome [2] 322725 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] 322725 0
Baseline and after 8 weeks.
Primary outcome [3] 322726 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] 322726 0
Baseline and after 8 weeks.
Secondary outcome [1] 379477 0
Assessment of trunk extensors endurance measures was tested with the Biodex Multi-Joint 3 Isokinetic Dynamometer.
Parameter: Total Work (TW).
Timepoint [1] 379477 0
Baseline and after 8 weeks
Secondary outcome [2] 379565 0
Assessment of trunk flexors endurance measures was tested with the Biodex Multi-Joint 3 Isokinetic Dynamometer.
Parameter: Total Work (TW).
Timepoint [2] 379565 0
Baseline and after 8 weeks
Secondary outcome [3] 379566 0
Assessment of trunk extensors endurance measures was tested with the Biodex Multi-Joint 3 Isokinetic Dynamometer.
Parameter: Average Power (AP).
Timepoint [3] 379566 0
Baseline and after 8 weeks
Secondary outcome [4] 379567 0
Assessment of trunk flexors endurance measures was tested with the Biodex Multi-Joint 3 Isokinetic Dynamometer.
Parameter: Average Power (AP).
Timepoint [4] 379567 0
Baseline and after 8 weeks
Secondary outcome [5] 379568 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 [5] 379568 0
Baseline and after 8 weeks.

Eligibility
Key inclusion criteria
-women treated due to breast cancer (with a radical or saving procedure);
-period of at least 1 year since treatment;
-completed adjuvant therapy in the form of radiotherapy, chemotherapy or hormonotherapy;
-signed consent for participation in the study and exercise program.
Minimum age
45 Years
Maximum age
75 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
-lymphedema of the upper extremities;
-comorbidities in the form of orthopaedic, cardiological, neurological or oncological (cancers other than breast cancer) illnesses;
-mental state not allowing communication with the participant.

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
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] 22312 0
Poland
State/province [1] 22312 0

Funding & Sponsors
Funding source category [1] 304843 0
University
Name [1] 304843 0
University School of Physical Education in Wroclaw
Address [1] 304843 0
al.Ignacego Jana Paderewskiego 35
51-612 Wroclaw
Country [1] 304843 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] 305177 0
None
Name [1] 305177 0
Address [1] 305177 0
Country [1] 305177 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305253 0
Senacka Komisja ds. Etyki Badan Naukowych przy Akademii Wychowania Fizycznego we Wroclawiu
Ethics committee address [1] 305253 0
al.Ignacego Jana Paderewskiego 35
51-612 Wroclaw
Ethics committee country [1] 305253 0
Poland
Date submitted for ethics approval [1] 305253 0
06/02/2018
Approval date [1] 305253 0
08/03/2019
Ethics approval number [1] 305253 0

Summary
Brief summary
Purpose: to determine differences in the isokinetic trunk muscle endurance and sagittal spinal curvatures after nordic walking intervention between middle-aged and older breast cancer survivors with the hypothesis that an age-relation would be found.
Materials and methods: At the very beginning, the study included 58 women after breast cancer treatment (completed 39 patients). They were randomly divided into 2 groups: study group (SG, n=19) participated in Nordic walking training vs control group (CG, n=20) subjected a standard general exercise programme. Both groups divided into age subgroup: middle-aged (45-59 years old) and older (60-75 years old) breast cancer survivors.
Before beginning 8-week training programs and after its completion, isokinetic trunk flexors and extensors endurance were determined, along with the sagittal spinal curves based on the photogrammetric method.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99778 0
Dr Justyna Hanuszkiewicz
Address 99778 0
Justyna Hanuszkiewicz, PhD
University School of Physical Education
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw, Poland
Country 99778 0
Poland
Phone 99778 0
+48713473520
Fax 99778 0
Email 99778 0
justyna.hanuszkiewicz@awf.wroc.pl
Contact person for public queries
Name 99779 0
Dr Justyna Hanuszkiewicz
Address 99779 0
Justyna Hanuszkiewicz, PhD
University School of Physical Education
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw, Poland
Country 99779 0
Poland
Phone 99779 0
+48713473520
Fax 99779 0
Email 99779 0
justyna.hanuszkiewicz@awf.wroc.pl
Contact person for scientific queries
Name 99780 0
Dr Justyna Hanuszkiewicz
Address 99780 0
Justyna Hanuszkiewicz, PhD
University School of Physical Education
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw, Poland
Country 99780 0
Poland
Phone 99780 0
+48713473520
Fax 99780 0
Email 99780 0
justyna.hanuszkiewicz@awf.wroc.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately after the publication of the material in the journal. End-date of availability: 6 months from publication.
Available to whom?
Only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
For IPD meta-analyses.
How or where can data be obtained?
IPD will be available by e-mail the principal investigator: justyna.hanuszkiewicz@awf.wroc.pl. Requirement to sign data access agreement.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6818 0
Ethical approval
Citation [1] 6818 0
Link [1] 6818 0
Email [1] 6818 0
Other [1] 6818 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary