Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes: Protocol for a Randomized Control Trial: DIACTIVE

Registration

Registration

NCT06745544

Acronym

DiaACTIVE

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Status

RECRUITING

Enrollment

490

Start

2025-10-01

Primary completion

2026-12-31

Lead sponsor

Aalborg University Hospital

Conditions

Type 2 Diabetes; Osteoporosis; Diabetic Neuropathies; Fall Prevention; Cardiovascular Diseases

Interventions

OTHER:Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL)

Results posted

FALSE

Individual participant data sharing

YES

Secondary identifiers

OTHER_GRANT:NNF22SA0079901

Registered primary outcomes

• Reduction in Fall Rates [Measurements will take place at 26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention to evaluate both short- and long-term effects of the intervention.]
• Improvement in Bone Mineral Density (BMD) [Measurements will assess changes at 26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention to evaluate sustained benefits.]
• Reduction in Cardiovascular Risk and Events [26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.]
• Improvement in Nerve Function [26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.]
• Blood glucose changes [HbA1c measurements will take place at baseline and after 26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention to evaluate both short- and long-term effects of the intervention. CGM will be measures blinded during the 26 weeks RYMA intervention.]