Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-29 @ 8:55 PM
Study NCT ID:
NCT07075367
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of an Exercise Program on Clinical Aspects of People With Diabetic Peripheral Neuropathy
Sponsor:
Federal University of Piaui
Organization:
Study Overview
Official Title:
Effect of a Trunk, Hip, Knee and Ankle Exercise Program on Clinical Aspects of People With Diabetic Peripheral Neuropathy: a Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diabetic Peripheral Neuropathy (DPN) is one of the most prevalent and debilitating complications of type 2 diabetes mellitus (DM2), especially affecting the distal region of the lower limbs. Such changes affect clinical aspects, such as quality of life. Several pieces of evidence point to therapeutic exercises as an effective way to minimize these deficits. This is a single-blind randomized clinical trial in which participants will be randomly assigned to two groups. The stipulated sample size was 64 participants. The experimental group will receive a distal/proximal exercise program and the control group will receive a distal exercise program available in the literature and previously tested. The intervention will last 12 weeks and will take place twice a week, with an average time of 50 minutes. Neuropathic symptoms will be considered primary outcomes. The secondary outcomes evaluated will be: capillary blood glucose, Mini-BESTest, Falls Efficacy Scale (FES), EQ-5D and HADS (depression and anxiety). This study was approved by the local research ethics committee (Opinion 6.802.243), conducted in accordance with the Declaration of Helsinki and in accordance with the CONSORT guidelines.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: