Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000335796
Ethics application status
Approved
Date submitted
13/07/2021
Date registered
23/02/2022
Date last updated
23/02/2022
Date data sharing statement initially provided
23/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence of Physical Activity on Blood Indicators and Vitamin D Level in the Blood of Elderly
Scientific title
Influence of Nordic Walking Training and Cycle Ergometer Trainning on Biochemical, Morphological, Rheological Indicators and Vitamin D Level in the Blood of Women Aged 65-74
Secondary ID [1] 304105 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopaenia 321781 0
Vitamin D deficiency 321785 0
Quality of life 321786 0
Aging process 321787 0
Condition category
Condition code
Physical Medicine / Rehabilitation 319514 319514 0 0
Physiotherapy
Mental Health 319516 319516 0 0
Studies of normal psychology, cognitive function and behaviour
Diet and Nutrition 322450 322450 0 0
Other diet and nutrition disorders
Musculoskeletal 322451 322451 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
• The first experimental group (NW) - this group consisted of 20 women who underwent a 6-month Nordic walking training.
• The second experimental group (R) - this group consisted of 18 women who underwent a 6-month training on a cycloergometer.
NW group
The subjects in the NW group underwent 6-month (72 sessions) Nordic walking training. Classes were held outdoors (park) 3 times a week from April to September 2019. The duration of each training unit was 1 hour, which consisted of:
• introductory part (about 10 minutes) - to warm up and prepare the body, including strengthening and stretching exercises (Borg 6-8 scale),
• main part (about 45 minutes) - in this part, the participants marched using the Nordic walking technique with the intensity defined at the level of the first ventilation threshold (VT1), during which the optimal heart rate (HR) was determined (Borg scale 10-12) ,
• final part (approx. 5-10 minutes) - calming down, consisting of stretching, breathing and relaxation exercises (Borg 6-8 scale).
All sessions were providing by physiotherapists in groups of no more than 10 people. Session attendence checklist were checked before start the every session.
Before starting the program, the respondents participated in 3 classes (weekly 1-hour) aimed at getting acquainted with the correct technique of Nordic walking. Classes were providing by physiotherapists.

Group R.
The subjects in group R underwent a 6-month training (72 sessions) on cycloergometers. Classes were held in a gym equipped with stationary bicycles, 3 times a week from April to September 2019. The duration of each training unit was 1 hour, which consisted of:
• introductory part (approx. 10 minutes) - aimed at warming up and preparing the body for the main part of the training. The subjects pedaled with an intensity determined on the Borg scale at 6-8,
• main part (about 45 minutes) - in this part, the subjects pedaled with the intensity defined at the level of the first ventilation threshold (VT1), during which the optimal heart rate (HR) was determined (Borg 10-12),
• final part (approx. 5-10 minutes) - for calming down, during which the participants will pedal with an intensity determined on the Borg scale at 6-8.
All sessions were providing by physiotherapists in groups of no more than 10 people. Session attendence checklist were checked before start the every session.

Intervention code [1] 320439 0
Prevention
Intervention code [2] 320440 0
Rehabilitation
Intervention code [3] 320441 0
Lifestyle
Comparator / control treatment
Active: no intervention given (observation only).
Control group
Active

Outcomes
Primary outcome [1] 327515 0
Assessment of changes in rheological properties of blood such as the erythrocyte elongation index (EI), erythrocyte aggregation indexes (AI), i.e. AMP - total aggregation, T1/2 - half time of total aggregation and fibrinogen level which were determined using Analizator Laser-assisted Optical Rotational Cell Analyser (LORCA) RR Mechatronics.
Timepoint [1] 327515 0
Baseline, 3 months post commencement of intervention/observation, 6 months (primary endpoint) post commencement of intervention/observation
Primary outcome [2] 327516 0
Assessment of changes in hematological properties of blood such as the red blood cell count (RBC), white blood cell count (WBC), hemoglobin level (HGB), hematocrit (HCT), platelets count (PLT), mean corpuscular hemoglobin/mean cell hemoglobin (MCH), mean corpuscular volume (MCV), mean corpuscular hemoglobin concentration which were determined using ABX MICROS 60 (USA) hematology analyzer.
Timepoint [2] 327516 0
Baseline, 3 months post commencement of intervention/observation, 6 months (primary endpoint) post commencement of intervention/observation
Primary outcome [3] 327517 0
Evaluation of changes in the level of calcidiol (D-OH 25) in blood serum by enzyme-linked immunosorbent method (ELISA) using high-sensitivity reagent kits from DRG Instruments Gmbh (Germany)
Timepoint [3] 327517 0
Baseline, 3 months post commencement of intervention/observation, 6 months (primary endpoint) post commencement of intervention/observation
Secondary outcome [1] 395492 0
Evaluation of changes in the lipid profiles: high density lipoprotein (HDL) which was was determined using the precipitation method, polyethylene glycol-modified cholesterol esterase and cholesterol oxidase were used for the purpose of community application, low density lipoprotein (LDL) which was was calculated automatically for each blood sample analyzed using the direct determination of total cholesterol, HDL and triglicerydes (TG) and the standard Friedewald formula, triglicerydes (TG) by enzymatic end-point method using 4 enzymes: lipase, glycerol kinase, glycerol-3-phosphate dehydrogenase, diaphorase.
Timepoint [1] 395492 0
Baseline, 3 months post commencement of intervention/observation, 6 months post commencement of intervention/observation
Secondary outcome [2] 395493 0
Assessment of changes in protein profile such as total protein, albumins, alpha-1-globulin, alpha-2-globulin, beta-1-glubulin, beta-2-globulin, gamma-globulin, albumin/globulin ratio which were determined using Cobas 6000, Roche analyzer. The measurement was carried out according to the principles of the colorimetric test - the biuret method. For the measurement blood samples were used.
Timepoint [2] 395493 0
Baseline, 3 months post commencement of intervention/observation, 6 months post commencement of intervention/observation
Secondary outcome [3] 395494 0
Evaluation of changes in the insulin level. The electrochemiluminescence test "ECLIA" using the Elecsys / Cobas e 602 analyzer was used to determine the level of insulin in the blood. Measurements were made in accordance with the sandwich test control.
Timepoint [3] 395494 0
Baseline, 3 months post commencement of intervention/observation, 6 months post commencement of intervention/observation
Secondary outcome [4] 395495 0
Evaluation of changes in the iron level which were determined using a colorimetric test - ferrosine method without deproteinization. The tests were performed using the Cobas c 501 analyzer. For the measurement blood samples were used.
Timepoint [4] 395495 0
Baseline, 3 months post commencement of intervention/observation, 6 months post commencement of intervention/observation
Secondary outcome [5] 398244 0
Evaluation of functional fitness using Senior Fitness Test (Fullerton test).
Timepoint [5] 398244 0
Baseline, 3 months post commencement of intervention/observation, 6 months post commencement of intervention/observation
Secondary outcome [6] 398245 0
Quality of life assessed using the SF-36 Quality of Life Questionnaire
Timepoint [6] 398245 0
Baseline, 3 months post commencement of intervention/observation, 6 months post commencement of intervention/observation

Eligibility
Key inclusion criteria
- Female,
- age: 65-74 years old,
- no previous contact with Nordic walking training or on a cyclo-ergometer,
- a medical certificate that there are no contraindications to exercise,
- written consent to voluntary participation in the research project.
Minimum age
65 Years
Maximum age
74 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Unregulated hypertension,
- heart arythmia,
- diabetes,
- cancer,
- a period within 5 years from the end of oncological treatment,
- taking medications that affect blood flow through the blood vessels,
- vitamin D supplementation,
- participating in other forms of physical activity during the project duration.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using ballot draw.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/01/2019
Date of last participant enrolment
Anticipated
Actual
29/03/2019
Date of last data collection
Anticipated
Actual
4/10/2019
Sample size
Target
60
Accrual to date
Final
55
Recruitment outside Australia
Country [1] 23959 0
Poland
State/province [1] 23959 0
Malopolska

Funding & Sponsors
Funding source category [1] 308488 0
University
Name [1] 308488 0
University of Physical Education in Cracow
Country [1] 308488 0
Poland
Primary sponsor type
Individual
Name
Szymon Podsiadlo
Address
University of Physical Education in Cracow
Institute of Clinical Rehabilitation, Department of Rehabilitation in Traumatology
al. Jana Pawla II 78
Kraków
Post code: 31-571
Poland
Country
Poland
Secondary sponsor category [1] 309336 0
Individual
Name [1] 309336 0
Agnieszka Skiba
Address [1] 309336 0
University of Physical Education in Cracow
Institute of Clinical Rehabilitation, Department of Rehabilitation in Rheumatology and Geriatrics
al. Jana Pawla II 78
Kraków
Post code: 31-571
Poland
Country [1] 309336 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308441 0
Bioethical Commission of the Regional Medical Chamber in Krakow
Ethics committee address [1] 308441 0
Ethics committee country [1] 308441 0
Poland
Date submitted for ethics approval [1] 308441 0
Approval date [1] 308441 0
11/12/2018
Ethics approval number [1] 308441 0
126/MN/KRK/2018

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

Contacts
Principal investigator
Name 110722 0
Dr Szymon Podsiadlo
Address 110722 0
University of Physical Education in Cracow
Institute of Clinical Rehabilitation, Department of Rehabilitation in Traumatology
al. Jana Pawla II 78
Kraków
Post code: 31-571
Poland
Country 110722 0
Poland
Phone 110722 0
+48602212790
Fax 110722 0
Email 110722 0
[email protected]
Contact person for public queries
Name 110723 0
Szymon Podsiadlo
Address 110723 0
University of Physical Education in Cracow
Institute of Clinical Rehabilitation, Department of Rehabilitation in Traumatology
al. Jana Pawla II 78
Kraków
Post code: 31-571
Poland
Country 110723 0
Poland
Phone 110723 0
+48602212790
Fax 110723 0
Email 110723 0
[email protected]
Contact person for scientific queries
Name 110724 0
Szymon Podsiadlo
Address 110724 0
University of Physical Education in Cracow
Institute of Clinical Rehabilitation, Department of Rehabilitation in Traumatology
al. Jana Pawla II 78
Kraków
Post code: 31-571
Poland
Country 110724 0
Poland
Phone 110724 0
+48602212790
Fax 110724 0
Email 110724 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
No additional documents have been identified.