NCT02633891

Metabolic Syndrome and Fall Risk

Completed NA Results posted Last updated 28 June 2024

What this trial tests

NA trial testing Balance exercise in Metabolic Syndrome in 12 participants. Completed in 28 March 2022.

Timeline

2 January 2017

Primary endpoint
28 March 2022

28 March 2022

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	12
Start date	2 January 2017
Primary completion	28 March 2022
Estimated completion	28 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Balance exercise
• Standard care — full drug profile →

Conditions studied

• Metabolic Syndrome — all drugs for Metabolic Syndrome →
• Autonomic Neuropathy — all drugs for Autonomic Neuropathy →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 45 to 75, any sex, with Metabolic Syndrome or Autonomic Neuropathy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Four Square Step Test (FSST) Primary · 12 weeks

A measure of proactive dynamic standing balance. A participant steps over four canes that are laid on the ground at 90 degree angles to each other. The participants stands in one of the squares formed by the canes and they are instructed to step as quickly as possible into each square in a specified sequence.

Group	Value	95% CI
Balance Exercise Program	11.04	9.9 – 12.93
Standard Care	14.29	9.28 – 25.47

Dynamic Gait Index (DGI) Secondary · 12 weeks

An instrumented DGI will be performed on an instrumented gait mat. The DGI is a measure of functional balance during walking and it assesses an individual's ability to modify balance while walking in the presence of external demands (walking while changing speeds, head turns, stepping over and around obstacles, pivoting, and stair climbing). The short form DGI is scored 0-12, with higher number indicating better performance.

Group	Value	95% CI
Balance Exercise Program	9.33	8 – 10
Standard Care	7.5	3 – 11

Sponsor's own description

Obesity and the metabolic syndrome (MetS) are rapidly growing problems. Individuals with the MetS are at risk for not only future chronic diseases, but they have a higher prevalence of neuropathy, including cardiac autonomic neuropathy, and have a higher incidence of falls. Currently there are no effective therapies to prevent or reverse the neuropathy seen in the MetS or to reduced the fall risk in this population. This research project will determine if a tailored balance exercise program will have functional benefits and result in a reduced fall risk in the growing population of patients with the MetS and neuropathy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.