Time-specific Exercise in Circadian Context

NCT ID: NCT06746649

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-03-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteopenia Osteoporosis Aging

Keywords

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bone mineral density circadian rhythm elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In total, 34 previously untrained elderly subjects of both sexes, age range 65 - 80-year-old, will be recruited according to inclusion and exclusion criteria and will undergo the intervention.

The subject will be randomly assigned to the three groups:

a morning training group (n=14, 5 men, 9 women) an afternoon training group (n=14, 5 men, 9women) a control group (n=6, 6 women) Both men and women will be included to address the potential differences between sexes and to increase the clinical and practical relevance, since women make up more than 50 percent of clients visiting the Centre of Active Aging.

The duration of the training intervention is 12 weeks with the frequency 2 times per week.

The relative volume and intensity of the training for both training groups will be identical, except for timing of the training. The morning group and afternoon group will exercise exclusively between 08:00 - 09:00 h and 16:00 - 17:00 h, respectively.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Due to the time-specificity of the training design there is no possibility to mask the subject distribution.

Study Groups

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Morning group

The experimental factor will be applied in the morning (8:00-9:00).

Group Type EXPERIMENTAL

Combined training

Intervention Type PROCEDURE

12-week long time specific combined training 2 times a week

Afternoon group

The experimental factor will be applied in the afternoon (16:00-17:00).

Group Type EXPERIMENTAL

Combined training

Intervention Type PROCEDURE

12-week long time specific combined training 2 times a week

Control group

None expertimental factor will be aplied

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Combined training

12-week long time specific combined training 2 times a week

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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.


* 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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Comenius University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Bratislava, , Slovakia

Site Status

Countries

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Slovakia

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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APVV-21-0164

Identifier Type: -

Identifier Source: org_study_id