Time-specific Exercise in Circadian Context | NCT06746649

Studies
Time-specific Exercise in Circadian Context

NCT06746649

Sponsor

Comenius University

Status

Active, not recruiting

Last Update Posted

Dec 24, 2024Actual

Enrollment

34Actual

Phase

Not Applicable

Conditions

Osteopenia
Osteoporosis
Aging

Interventions

Combined training

Countries

Slovakia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2024Actual

Primary Completion Date

Jul 4, 2024Actual

Completion Date

Mar 30, 2025Estimated

First Submitted Date

Jun 11, 2024

First Submission Date that Met QC Criteria

Dec 17, 2024

First Posted Date

Dec 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2024

Last Update Posted Date

Dec 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Morning group	Experimental	The experimental factor will be applied in the morning (8:00-9:00).	Procedure: Combined training
Afternoon group	Experimental	The experimental factor will be applied in the afternoon (16:00-17:00).	Procedure: Combined training
Control group	No Intervention	None expertimental factor will be aplied

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Combined training	Procedure	12-week long time specific combined training 2 times a week	Afternoon group Morning group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bone mineral density	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

80 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Comenius University in Bratislava, Faculty of physical education and sport Bratislava, Slovakia		Bratislava		814 99	Slovakia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 16, 2024	Dec 16, 2024	Prot_SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D001851	Bone Diseases, Metabolic
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.