Time-specific Exercise in Circadian Context (CAEx)

December 17, 2024 updated by: Comenius University

Healthy Aging: Effects of Time-specific Exercise on Functional, Structural, Metabolic and Immune Parameters in Circadian Context

The project aims to explore the mechanisms, by which physical activity can support healthy ageing and decrease the negative impact of ageing on the circadian system, musculoskeletal system and immunity.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The main aim of the project is to examine the effect of as well as of the three-month, timely specific training intervention on the functionality of circadian organization in elderly volunteers. The additive aim is to examine the effect of lifelong endurance physical activity, along with the experimental training intervention on the body composition, bone density, and selected hormonal, biochemical, histological and molecular indicators of metabolic health.

Partial aims are as follows:n to explore the effect of morning and afternoon training on the most significant parameters, identified by the previous cross-sectional study, in sedentary elderly. Furthermore, to clarify adaptation mechanisms of experimental training protocol on selected parameters, that may explain possible differences in mechanisms of active and passive aging.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • Bratislava, Slovakia, 814 99
        • Comenius University in Bratislava, Faculty of physical education and sport Bratislava, Slovakia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • no history of regular physical activity training and exercise of more than 150 minutes of moderate or 75 minutes of higher intensity per week.
  • Body mass index (BMI) between 18.5 and 30 kg/m2 for all groups

Exclusion criteria for probands will be:

  • Recent or current infection, physical disability,
  • malignant, cardiovascular, metabolic, autoimmune diseases,
  • Malnutrition and pharmacological interference (e.g., steroids, non-steroidal anti-inflammatory agents, immunosuppressive and antineoplastic drugs).

Use of performance enhancing drugs in the past and during the study period will condition exclusion.

Exclusion Criteria:

  • recent or current infection, physical disabilities,
  • malignant, cardiovascular, metabolic, autoimmune diseases,
  • Malnutrition and pharmacological interference (e.g., steroids, nonsteroidal anti-inflammatory agents, immunosuppressive and antineoplastic drugs).

Use of performance-enhancing drugs in the past and during the study period will condition exclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Morning group
The experimental factor will be applied in the morning (8:00-9:00).
Procedure: Combined training
12-week long time specific combined training 2 times a week
Experimental: Afternoon group
The experimental factor will be applied in the afternoon (16:00-17:00).
Procedure: Combined training
12-week long time specific combined training 2 times a week
No Intervention: Control group
None expertimental factor will be aplied

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone mineral density
Time Frame: 12 weeks
The proportion of total body fat mass, visceral fat mass, total body mass and bone density will be measured using Dual-energy X-ray Absorptiometry (DXA, hologic fan-beam bone densitometer Discovery QDR series). The DXA testing procedure will follow Kralik et al. (2019). All DXA procedures will be performed by a board-certified radiologist.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Comenius University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

July 4, 2024

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

December 17, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APVV-21-0164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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