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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

2/02/2021

Date data sharing statement 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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

breast cancer

Condition category

Condition code

Cancer

Breast

Physical Medicine / Rehabilitation

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]

Rehabilitation

Intervention code [2]

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]

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]

Baseline and after 8 weeks.

Primary outcome [2]

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]

Baseline and after 8 weeks.

Primary outcome [3]

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]

Baseline and after 8 weeks.

Secondary outcome [1]

Assessment of trunk extensors endurance measures was tested with the Biodex Multi-Joint 3 Isokinetic Dynamometer.
Parameter: Total Work (TW).

Timepoint [1]

Baseline and after 8 weeks

Secondary outcome [2]

Assessment of trunk flexors endurance measures was tested with the Biodex Multi-Joint 3 Isokinetic Dynamometer.
Parameter: Total Work (TW).

Timepoint [2]

Baseline and after 8 weeks

Secondary outcome [3]

Assessment of trunk extensors endurance measures was tested with the Biodex Multi-Joint 3 Isokinetic Dynamometer.
Parameter: Average Power (AP).

Timepoint [3]

Baseline and after 8 weeks

Secondary outcome [4]

Assessment of trunk flexors endurance measures was tested with the Biodex Multi-Joint 3 Isokinetic Dynamometer.
Parameter: Average Power (AP).

Timepoint [4]

Baseline and after 8 weeks

Secondary outcome [5]

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]

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

Sex

Females

Can healthy volunteers participate?

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

25/03/2019

Date of last participant enrolment

Anticipated

Actual

26/04/2019

Date of last data collection

Anticipated

Actual

21/06/2019

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

University School of Physical Education in Wroclaw

Address [1]

al.Ignacego Jana Paderewskiego 35
51-612 Wroclaw

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Senacka Komisja ds. Etyki Badan Naukowych przy Akademii Wychowania Fizycznego we Wroclawiu

Ethics committee address [1]

al.Ignacego Jana Paderewskiego 35
51-612 Wroclaw

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

06/02/2018

Approval date [1]

08/03/2019

Ethics approval number [1]

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

Dr Justyna Hanuszkiewicz

Address

Justyna Hanuszkiewicz, PhD
University School of Physical Education
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw, Poland

Country

Poland

Phone

+48713473520

Fax

[email protected]

Contact person for public queries

Name

Justyna Hanuszkiewicz

Address

Justyna Hanuszkiewicz, PhD
University School of Physical Education
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw, Poland

Country

Poland

Phone

+48713473520

Fax

[email protected]

Contact person for scientific queries

Name

Justyna Hanuszkiewicz

Address

Justyna Hanuszkiewicz, PhD
University School of Physical Education
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw, Poland

Country

Poland

Phone

+48713473520

Fax

[email protected]

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: [email protected]. Requirement to sign data access agreement.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
6818	Ethical approval					379180-(Uploaded-07-02-2020-21-48-56)-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

Source	Title	Year of Publication	DOI
Embase	The influence of nordic walking on isokinetic trunk muscle endurance and sagittal spinal curvatures in women after breast cancer treatment: Age-specific indicators.	2021	https://dx.doi.org/10.3390/ijerph18052409

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically