Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000268741
Ethics application status
Approved
Date submitted
2/08/2021
Date registered
14/02/2022
Date last updated
14/02/2022
Date data sharing statement initially provided
14/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physical activity in multiple myeloma patients - its impact on various blood parameters and physical fitness
Scientific title
The impact of Nordic walking trainings on functional efficiency and the various blood parameters of patients with multiple myeloma
Secondary ID [1] 303431 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple myeloma 320734 0
Condition category
Condition code
Cancer 318574 318574 0 0
Myeloma
Physical Medicine / Rehabilitation 319072 319072 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nordic walking (NW) training sessions are performed in groups for 6 weeks, 3 times a week, in the morning, at University of Physical Education in Krakow by a qualified instructor. Before the first training session, the length of the poles is adjusted for each participant individually. The participants are also acquainted with the correct walking technique, which is monitored and adjusted in each participant during the trainings. Heart rate is controlled individually in each participant with use of sport-tester watch.
Each session consists of a 10-minute warm-up. The main part is 45 minutes long and consists of a practice with poles and walking with the correct Nordic walking technique. The walking time is extended with each training session, until it reached a maximum of 45 minutes. At the end, a 5-minute calming part is performed (calming and stretching exercises).
Attendance of participants in training sessions is monitored with use of a session attendance checklist (required attendance: over 80%).
Intervention code [1] 319736 0
Rehabilitation
Intervention code [2] 322204 0
Treatment: Other
Comparator / control treatment
Multiple myeloma patients not participating in trainings.
Control group
Active

Outcomes
Primary outcome [1] 326531 0
Changes in blood parameters related with the disease after 3, 6 and 9 weeks of training sessions (full blood count, beta-2-microglobulin, serum monoclonal protein concentration, immunoglobulins, kappa and lambda light chains).
This will be assessed as a composite outcome.
Timepoint [1] 326531 0
Blood collection at baseline, after 3, 6 and 9 weeks from the beginning of training cycle.
Primary outcome [2] 326532 0
Changes in blood parameters related with oxidative stress after 3, 6 and 9 weeks of training sessions (serum pro-antioxidative balance parameters, markers of macromolecules' oxidatve damages, iron metabolism parameters, activity of antioxidative enzymes in erythrocytes, and expression of related genes in leukocytes).
This will be assessed as a composite outcome.
Timepoint [2] 326532 0
Blood collection at baseline, after 3, 6 and 9 weeks from the beginning of training cycle.
Primary outcome [3] 326533 0
Changes in blood parameters related with inflammation after 3, 6 and 9 weeks of training sessions (serum levels of selected pro- and anti-inflammatory cytokines and expression of related genes in leukocytes).
This will be assessed as a composite outcome.
Timepoint [3] 326533 0
Blood collection at baseline, after 3, 6 and 9 weeks from the beginning of training cycle.
Secondary outcome [1] 391795 0
Changes in functional efficiency after 6 weeks cycle of training sessions with use of Fullerton Senior Fittness Test.
Timepoint [1] 391795 0
Performed before and after 6 weeks of training sessions.
Secondary outcome [2] 403056 0
Assesment of diet composition performed with use of 5-days food diaries and software for diet analysis (Dieta 6, IZZ, Poland).
Timepoint [2] 403056 0
Performed before and after 6 weeks of training sessions.
Secondary outcome [3] 403057 0
Physical activity assesment - IPAQ questionnaire.
Timepoint [3] 403057 0
Performed before and after 6 weeks of training sessions.
Secondary outcome [4] 403058 0
Anthropmetric parameters measurement (selected skin-folds with use of antropometer, selected body circumferences - with use of anthropometric tape).
Timepoint [4] 403058 0
Performed before and after 6 weeks of training sessions.
Secondary outcome [5] 403060 0
Medical interview with patient including frailty and sacropenia assesment (with use of questionnaires: SARC-F and PRISMA) - composite outcome.
Timepoint [5] 403060 0
Performed before and after 6 weeks of training sessions.

Eligibility
Key inclusion criteria
• Multiple myeloma in plateau stage, without cytostatic treatment
• Acceptable bisphosphonate therapy
• General good condition of the patient (ECOG scale: 0,1,2)
• No contraindications to participate in health training
• Cardiovascular capacity on the NYHA scale 1-2
• No chronic respiratory diseases
• No other neoplastic disease
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Active anti-cancer treatment
• Significant liver and kidney damage
• High hypercalcemia
• An infectious disease
• Acute respiratory infections
• Fall from own height complicated with limb and torso trauma during the project duration

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/02/2019
Date of last participant enrolment
Anticipated
30/09/2022
Actual
Date of last data collection
Anticipated
30/11/2022
Actual
Sample size
Target
50
Accrual to date
28
Final
Recruitment outside Australia
Country [1] 23461 0
Poland
State/province [1] 23461 0
Lesser Poland

Funding & Sponsors
Funding source category [1] 307852 0
University
Name [1] 307852 0
Univesrity of Physical Education in Kraków
Country [1] 307852 0
Poland
Funding source category [2] 307853 0
University
Name [2] 307853 0
Jagiellonian University Medical College
Country [2] 307853 0
Poland
Primary sponsor type
Individual
Name
Olga Czerwinska-Ledwig, PhD
Address
University of Physical Education in Kraków
Faculty of Motor Rehabilitation
al. Jana Pawla II 78
31-571 Krakow
Country
Poland
Secondary sponsor category [1] 308561 0
Individual
Name [1] 308561 0
prof. Artur Jurczyszyn, MD, PhD
Address [1] 308561 0
Jagiellonian University Medical College
Department of Hematology
ul. Kopernika 17
31-501 Kraków
Country [1] 308561 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307857 0
The Ethical Committee of Regional Medical Chamber in Krakow
Ethics committee address [1] 307857 0
Ethics committee country [1] 307857 0
Poland
Date submitted for ethics approval [1] 307857 0
Approval date [1] 307857 0
21/09/2018
Ethics approval number [1] 307857 0
166/KBL/OIL/2018

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

Contacts
Principal investigator
Name 108722 0
Dr Olga Czerwinska-Ledwig
Address 108722 0
University of Physical Education in Kraków
al. Jana Pawla II 78
31-571 Krakow
Country 108722 0
Poland
Phone 108722 0
+48 12 6831154
Fax 108722 0
Email 108722 0
[email protected]
Contact person for public queries
Name 108723 0
Olga Czerwinska-Ledwig
Address 108723 0
University of Physical Education in Kraków
al. Jana Pawla II 78
31-571 Krakow
Country 108723 0
Poland
Phone 108723 0
+48 12 6831154
Fax 108723 0
Email 108723 0
[email protected]
Contact person for scientific queries
Name 108724 0
Artur Jurczyszyn, MD, PhD
Address 108724 0
Jagiellonian University Medical College
Department of Hematolog
ul. Kopernika 17
30-501 Kraków
Country 108724 0
Poland
Phone 108724 0
+48 124247600
Fax 108724 0
Email 108724 0
[email protected]

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 Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of a 6-Week Cycle of Nordic Walking Training on Vitamin 25(OH)D3, Calcium-Phosphate Metabolism and Muscle Damage in Multiple Myeloma Patients-Randomized Controlled Trial.2022https://dx.doi.org/10.3390/jcm11216534
EmbaseThe Effect of a Six-Week Nordic Walking Training Cycle on Oxidative Damage of Macromolecules and Iron Metabolism in Older Patients with Multiple Myeloma in Remission-Randomized Clinical Trial.2023https://dx.doi.org/10.3390/ijms242015358
Dimensions AIRheological properties of blood in multiple myeloma patients2024https://doi.org/10.1038/s41598-024-54947-4
N.B. These documents automatically identified may not have been verified by the study sponsor.