NCT03550105

Brief Summary

Physical Inactivity and excessive sedentary behavior are risk factors for diabetes and cardiovascular disease. Movement is important for overall health. This study will assess the validity and usefulness of low risk, non-invasive wellness device, the Gentle Jogger® (GJ) that passively simulates the physical activities of jogging. The study will evaluate whether or not use of GJ modifies glycemic control and muscle strength in subjects who are known to be diabetic and those who are not. The study volunteers are subjects between the ages of 25-80yr.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 1, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 5, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2020

Completed
Last Updated

January 27, 2020

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

May 1, 2018

Last Update Submit

January 23, 2020

Conditions

Diabetes MellitusGlucose Metabolism DisordersPhysical Activity

Keywords

GlucoseDiabetesPhysical ActivityPassive ExerciseBlood PressureMuscle StrengthMuscle EnduranceHypertensionPhysical Inactivity

Outcome Measures

Primary Outcomes (1)

  • Glycemic Control

    For GJ-OGTT Group: Blunting of the peak and decrease of the area under the curve of the Oral Glucose Tolerance after 7 days of Gentle Jogger For GJ-Only Blunting or decreased of basal glucose levels ( 3 days prior to GJ) compared to glucose levels after 7 days of GJ

    8 days

Secondary Outcomes (5)

  • Variability of Glycemic Control - (24 hrs Standard Deviation of Glycemia)

    8 Days

  • Muscle Strength

    8 days

  • Muscle Endurance

    8 days

  • Carry Over Effect of Muscle Strength

    14 days

  • Carry Over Effect of Muscle Endurance

    14 days

Study Arms (2)

GJ-Only

EXPERIMENTAL

Study Subjects with Baseline Glucose of \> 150mg/dl, will have Gentle Jogger Only for 7 days

Device: Gentle Jogger

GJ-OGTT

EXPERIMENTAL

Study Subjects with Baseline Glucose of \< 150mg/dl, will have Oral Glucose Tolerance Test (OGTT) at baseline and after 7 days of Gentle Jogger

Device: Gentle Jogger

Interventions

Gentle JoggerDEVICE

Gentle Jogger is a passive simulated jogging device to be used 3 times per day for at least 30 mins for 7 days in this study

GJ-OGTTGJ-Only

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers able to consent ages 25-80yrs
  • Known Diabetics (Type 1 or Type 2)- Previously diagnosed by their physician on either Insulin and or oral diabetic medications ages 25-80yrs

You may not qualify if:

  • Younger than 25 yrs or Older than 80 yrs
  • Unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIC Miami

Miami, Florida, 33136, United States

Location

Related Publications (4)

  • Adams JA, Lopez JR, Nadkarni V, Zolkipli-Cunningham Z, Ischiropoulos H, Sackner MA. The effects of a motorized passive simulated jogging device on descent of the arterial pulse waveform dicrotic notch: A single arm placebo-controlled cross-over trial. Physiol Rep. 2022 Aug;10(15):e15418. doi: 10.14814/phy2.15418.

    PMID: 35924333DERIVED

  • Adams JA, Lopez JR, Banderas V, Sackner MA. The Effects of Passive Simulated Jogging on Parameters of Explosive Handgrip in Nondiabetics and Type 2 Diabetics: A Single Arm Study. Biomed Res Int. 2022 Feb 11;2022:6450844. doi: 10.1155/2022/6450844. eCollection 2022.

    PMID: 35187168DERIVED

  • Adams JA, Lopez JR, Banderas V, Sackner MA. A single arm trial using passive simulated jogging for blunting acute hyperglycemia. Sci Rep. 2021 Mar 19;11(1):6437. doi: 10.1038/s41598-021-85579-7.

    PMID: 33742027DERIVED

  • Adams JA, Banderas V, Lopez JR, Sackner MA. Portable Gentle Jogger Improves Glycemic Indices in Type 2 Diabetic and Healthy Subjects Living at Home: A Pilot Study. J Diabetes Res. 2020 Jan 21;2020:8317973. doi: 10.1155/2020/8317973. eCollection 2020.

    PMID: 32215273DERIVED

MeSH Terms

Conditions

Diabetes MellitusGlucose Metabolism DisordersMotor ActivityHypertensionSedentary Behavior

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A) Study Subjects with Baseline Glucose of \> 150mg/dl, will have Gentle Jogger Only for 7 days B) Study Subjects with Baseline Glucose of \< 150 mg/dl will have basal oral glucose tolerance test (OGTT) and repeat OGTT after 7 days of Gentle Jogger
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2018

First Posted

June 8, 2018

Study Start

June 5, 2018

Primary Completion

January 23, 2020

Study Completion

January 23, 2020

Last Updated

January 27, 2020

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)