NCT03417700

Brief Summary

Physical activity is a recommended, indispensable element of a healthy lifestyle as well as a countermeasure against many diseases often accompanied by the acute or chronic low grade inflammation. Papers published in recent years have demonstrated the anti-inflammatory effect of exercise. Based on current knowledge of the topic, own experience and preliminary work, it is expected the proposed research to provide information on the mechanism either determining or limiting pro-healthy effects of exercise in different age groups of people. Three different training programmes will be investigated. Specific goals of the project include the following:

  1. 1.Establish, whether regular Nordic Walking training and HIIT can reduce the low-grade systemic inflammation and which type of training is the most effective at doing so.
  2. 2.Establish, whether regular training can prevent muscle sarcopenia and assess if those changes are related to the concentration of the autophagy-inducing stress protein, HMGB1.
  3. 3.Establish, whether regular Nordic Walking training alters iron metabolism and evaluate its correlation with the inflammatory markers and bone-morphogenesis.
  4. 4.Establish, whether muscle-released irisin signals growth in the BDNF concentration in response to exercise and if these changes improve cognitive function.
  5. 5.Establish, whether Nordic Walking or HIIT training effectively improve the blood lipid profile and aerobic capacity, and if these effects correlate with the blood 25-OHD concentration.
  6. 6.Establish, whether concentration of vitamin D alters adaptation to training and modifies immunological response to regular training process.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 5, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

November 30, 2017

Last Update Submit

May 7, 2021

Conditions

Keywords

vitamin Dexercisetrainingaging

Outcome Measures

Primary Outcomes (1)

  • The influence of vitamin D on physical performance in aging people

    To verify if training supported by vitamin D supplementation will bring better effects

    Values at baseline will be compared to values recorded 12 weeks and 3 months after the training programme.

Study Arms (3)

Training NW

EXPERIMENTAL

exercise and supplementation

Dietary Supplement: NW trainingDietary Supplement: Placebo

Training HICT and vitamin D

EXPERIMENTAL

Training HICT plus vitamin D

Dietary Supplement: NW trainingDietary Supplement: PlaceboDietary Supplement: HICT

Placebo

EXPERIMENTAL

placebo Vitamin D

Dietary Supplement: NW training

Interventions

NW trainingDIETARY_SUPPLEMENT

NW training

Also known as: Training, vitamin D
PlaceboTraining HICT and vitamin DTraining NW
PlaceboDIETARY_SUPPLEMENT

training with placebo

Also known as: Control group
Training HICT and vitamin DTraining NW
HICTDIETARY_SUPPLEMENT

Training and vitamin D

Also known as: resistance training
Training HICT and vitamin D

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • no illness medical check

You may not qualify if:

  • uncontrolled hypertension (diastolic blood pressure over 100 mmHg), a history of cardiac arrhythmia, cardio-respiratory disorders, advanced osteoporosis, clinical diagnosis of Alzheimer's Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Physical Education and Sport

Gdansk, Pomeranian Voivodeship, 80-336, Poland

Location

Ziemann Ewa

Sopot, Pomeranian Voivodeship, 81-735, Poland

Location

Related Publications (6)

  • Gmiat A, Mieszkowski J, Prusik K, Prusik K, Kortas J, Kochanowicz A, Radulska A, Lipinski M, Tomczyk M, Jaworska J, Antosiewicz J, Ziemann E. Changes in pro-inflammatory markers and leucine concentrations in response to Nordic Walking training combined with vitamin D supplementation in elderly women. Biogerontology. 2017 Aug;18(4):535-548. doi: 10.1007/s10522-017-9694-8. Epub 2017 Mar 18.

  • Prusik K, Kortas J, Prusik K, Mieszkowski J, Jaworska J, Skrobot W, Lipinski M, Ziemann E, Antosiewicz J. Nordic Walking Training Causes a Decrease in Blood Cholesterol in Elderly Women Supplemented with Vitamin D. Front Endocrinol (Lausanne). 2018 Feb 20;9:42. doi: 10.3389/fendo.2018.00042. eCollection 2018.

  • Walentukiewicz A, Lysak-Radomska A, Jaworska J, Prusik K, Prusik K, Kortas JA, Lipinski M, Babinska A, Antosiewicz J, Ziemann E. Vitamin D Supplementation and Nordic Walking Training Decreases Serum Homocysteine and Ferritin in Elderly Women. Int J Environ Res Public Health. 2018 Sep 20;15(10):2064. doi: 10.3390/ijerph15102064.

  • Mieszkowski J, Niespodzinski B, Kochanowicz A, Gmiat A, Prusik K, Prusik K, Kortas J, Ziemann E, Antosiewicz J. The Effect of Nordic Walking Training Combined with Vitamin D Supplementation on Postural Control and Muscle Strength in Elderly People-A Randomized Controlled Trial. Int J Environ Res Public Health. 2018 Sep 7;15(9):1951. doi: 10.3390/ijerph15091951.

  • Gmiat A, Jaworska J, Micielska K, Kortas J, Prusik K, Prusik K, Lipowski M, Radulska A, Szupryczynska N, Antosiewicz J, Ziemann E. Improvement of cognitive functions in response to a regular Nordic walking training in elderly women - A change dependent on the training experience. Exp Gerontol. 2018 Apr;104:105-112. doi: 10.1016/j.exger.2018.02.006. Epub 2018 Feb 9.

  • Kortas J, Kuchta A, Prusik K, Prusik K, Ziemann E, Labudda S, Cwiklinska A, Wieczorek E, Jankowski M, Antosiewicz J. Nordic walking training attenuation of oxidative stress in association with a drop in body iron stores in elderly women. Biogerontology. 2017 Aug;18(4):517-524. doi: 10.1007/s10522-017-9681-0. Epub 2017 Feb 22.

MeSH Terms

Conditions

Motor Activity

Interventions

Vitamin DControl GroupsResistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ewa Ziemann

    Gdansk University of Physical Education and Sport, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Participants will receive vitamin D supplementation, but the dose will be known only to one investigator, who will be not be participating in any other assessment.
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Model I Women and men over 65 years old will participate in the training programme. All subjects will undergo a medical check-up before being subject to exercise. All procedures will be performed with the approval from the Bioethical Committee of the Regional Medical Society in Gdansk. One week prior to the beginning of the experiment, a battery of physiological and psychological tests will be performed. The same procedure will be repeated after the training period. In addtition to training, supplementation of vitamin D (800IU and 4000IU) will be administered. Model II Young women will participate in the training programme. They will perform a high-intensity circuit training according to the ACSM. They will perform a single session of HICT and 12 units of HICT regularly. One week prior to the beginning of the experiment, a battery of physiological and psychological test will be performed. The same procedure will be repeated after the training period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 30, 2017

First Posted

January 31, 2018

Study Start

January 5, 2018

Primary Completion

January 1, 2020

Study Completion

January 10, 2020

Last Updated

May 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Written-up results of research will be submitted for publication to international journals.

Locations