NCT04133129

Brief Summary

The project aims to find out the differences between two different types of structured training interventions have on the lipid profile of persons with diagnosed dyslipidemia. Each training intervention will last for 12 weeks. Subjects participating in the project will undergo a series of tests before and after the training intervention which will allow us to make conclusions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

October 16, 2019

Last Update Submit

October 18, 2019

Conditions

DyslipidemiasMetabolic SyndromeSedentary BehaviorObesityBlood Pressure

Keywords

HIITHigh Intensity Interval TrainingMedium Intensity Continuous TrainingInterval TrainingExercisePhysical ActivityExercise Training

Outcome Measures

Primary Outcomes (4)

  • Biochemical: Lipid Profile

    Evaluate change in Very Low-Density Lipoproteins (VLDL), High Density Lipoprotein (HDL), and Low-Density Lipoprotein (LDL) in (mg/dl) with Liposcale® test, an advanced lipoprotein test based on 2D Nuclear Magnetic Resonance (NMR).

    0 to 12 weeks

  • Blood Pressure (mmHg)

    Evaluate change in Systolic and Diastolic Blood Pressure

    0 to 12 weeks

  • Cardiorespiratory Fitness (ml/kg/min)

    Evaluate change in maximal oxygen uptake (VO2max) via breath by breath analysis performed on a treadmill.

    0 to 12 weeks

  • Changes in Body Composition (kg)

    Evaluate changes in Fat-free mass, fat mass, skeletal muscle mass measured by bio-electrical impedance analysis.

    0 to 12 weeks

Secondary Outcomes (2)

  • Changes in exercise enjoyment

    0 to 12 weeks

  • Change in Behavioural Regulations in Exercise Questionnaire-2 (BREQ-2) over time

    0 to 12 weeks

Study Arms (3)

LV-High Intensity Interval Training

EXPERIMENTAL

2 x 4 minutes at 85%-95% of Heart rate max.

Behavioral: Low Volume-High Intensity Interval Training

Moderate Intensity Continuous Training

EXPERIMENTAL

1 x 45 minutes at 65%-75% of Heart rate max.

Behavioral: Moderate Intensity Continuous Training

Control Group

NO INTERVENTION

They will not be prescribed any training and will be asked to continue with their normal lifestyle.

Interventions

Low Volume-High Intensity Interval TrainingBEHAVIORAL

On a treadmill, a 2 minute warm-up will be followed by 2 bouts of 4 minutes at an intensity between 85% and 95% of Maximum Heart Rate (HRmax) interspersed by a 2 minutes recovery bout at 70% of heart rate max, followed by a 3 minutes Cool Down

Also known as: HIIT, LV-HIIT
LV-High Intensity Interval Training
Moderate Intensity Continuous TrainingBEHAVIORAL

On a treadmill,a 2-minute warm-up will be followed by 45 minutes at 65%-75% of Heart Rate max followed by 3 minutes cool down.

Also known as: MICT
Moderate Intensity Continuous Training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fasted Blood Glucose \>100 mg/dL
  • Total Cholesterol \>200 mg/dL
  • Blood Pressure \>130/90 mmHg
  • Do not partake in more than 150 min/week of moderate to vigorous exercise

You may not qualify if:

  • Existing or past medical history of vascular disease, cancer, diabetes, osteoporosis, neurological, kidney, pulmonary, digestive (Coeliac disease), thyroidal disease.
  • Musculoskeletal injuries
  • Neuromuscular disorders or injuries
  • Individuals with a pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CDM GO fit Vallehermoso

Madrid, 28003, Spain

Location

MeSH Terms

Conditions

DyslipidemiasMetabolic SyndromeSedentary BehaviorObesityMotor Activity

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersBehaviorOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elizabeth Horton, PhD

    Coventry University

    STUDY DIRECTOR

  • Alfonso Jimenez, PhD

    GOfit and Sheffield Hallam University

    STUDY DIRECTOR

  • Ismael Serrablo, MSc

    Coventry University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ismael Serrablo, MSc

CONTACT

0034652950339serrabli@uni.coventry.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are only assigned to one of 3 possible groups for the duration of the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 21, 2019

Study Start

November 1, 2019

Primary Completion

March 2, 2020

Study Completion

March 31, 2020

Last Updated

October 21, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)