NCT06606678

Brief Summary

The goal of this clinical trial is to learn if regular physical activity can improve metabolic health, reduce inflammation, and decrease gut permeability in individuals aged 50 and older. The main questions it aims to answer are: Does regular physical activity, even at low intensity, improve metabolic parameters? Does physical activity reduce inflammation and gut permeability in older adults? Researchers will compare a group participating in low-intensity dance classes to a group participating in higher-intensity calisthenics training to see if the intensity of exercise has different effects on these outcomes. Participants will be asked to: Attend organized training sessions led by instructors twice a week for 12 months. Complete anthropometric measurements (height, weight) and body composition analysis (DXA scan). Provide blood samples for biochemical analysis (glucose, insulin, CRP, etc.). Submit stool samples for gut health markers (calprotectin, zonulin, etc.). Complete surveys on lifestyle and dietary habits before and after the study.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress59%
Sep 2024Jun 2027

Study Start

First participant enrolled

September 17, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 18, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

2.3 years

First QC Date

September 18, 2024

Last Update Submit

September 18, 2024

Conditions

Keywords

physical activitymetabolic healthinflammationgut functionolder adults

Outcome Measures

Primary Outcomes (1)

  • Improvement in insulin sensitivity

    To assess the primary outcome measure of improvement in insulin sensitivity, we will use the HOMA-IR index.

    before and after 12 months of intervention

Secondary Outcomes (1)

  • Reduction in gut inflammation

    before and after 12 months of intervention

Study Arms (1)

excercise

EXPERIMENTAL

supervised excercise training; twice a week for 12 months

Other: Exercise

Interventions

supervised exercise training; twice a week for 12 months

excercise

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 50 years
  • No contraindications for engaging in physical activity

You may not qualify if:

  • Presence of diseases that prevent participation in physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznań University of Physical Education

Poznan, 60-213, Poland

Location

MeSH Terms

Conditions

Metabolic DiseasesMotor ActivityInflammation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ewa Bryl, PhD

    Poznan Univeristy of Physical Education

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2024

First Posted

September 23, 2024

Study Start

September 17, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

September 23, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations