Time-specific Exercise in Circadian Context

NCT06746649 | Active Not Recruiting

• 1 other identifier: APVV-21-0164
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteopenia; Osteoporosis; Aging

Keywords

bone mineral density; circadian rhythm; elderly

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

Combined training PROCEDURE

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

Afternoon group; Morning group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• Comenius University: lead

Study Sites (1)

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

Bratislava, 814 99, Slovakia

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the time-specificity of the training design there is no possibility to mask the subject distribution.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: December 24, 2024
• Study Start: February 1, 2024
• Primary Completion: July 4, 2024
• Study Completion: March 30, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)