NCT04065191

Brief Summary

The aim of this study is to investigate the effects of an extremely time-efficient high-intensity interval training program, performed over a period of six months in a real-world (workplace) setting, on cardiorespiratory fitness, cardiometabolic risk profile, and self-reported outcomes including perceived stress and subjective work ability in previously sedentary employees.

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
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

May 15, 2019

Last Update Submit

August 20, 2019

Conditions

Primary PreventionHealth Promotion

Keywords

Aerobic exerciseCardiorespiratory FitnessHigh-intensity interval training (HIIT)WorkabilityPrevention

Outcome Measures

Primary Outcomes (1)

  • Cardiorespiratory Fitness (CRF)

    CRF will be assessed by measuring maximum oxygen uptake (VO2max)

    12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]

Secondary Outcomes (10)

  • Metabolic Syndrome Z-Score (MetS-Z-Score)

    12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]

  • Muscle mass

    12 months [Change from Baseline to 6 months and Change from baseline to 6 months after the end of the intervention]

  • Fat mass

    12 months [Change from baseline to 6 months and change from baseline to 6 months after the end of the intervention]

  • Total body water

    12 months [Change from baseline to 6 months and change from baseline to 6 months after the end of the intervention]

  • Insulin sensitivity

    12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]

  • +5 more secondary outcomes

Study Arms (1)

High-intensity interval training

EXPERIMENTAL

High-intensity interval training

Other: High-intensity interval training

Interventions

High-intensity interval trainingOTHER

Heart rate based high-intensity interval training

High-intensity interval training

Eligibility Criteria

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

You may qualify if:

  • Sedentary Lifestyle over at least 1 year prior to the study

You may not qualify if:

  • Pregnancy, Lactation
  • Psychological disorders, epilepsy, sever neurological disorders
  • Participation in other exercise- or nutrition studies within the last 6 months
  • coronary heart disease, heart failure
  • malignant disease
  • severe rheumatic or neurological disease
  • severe/unstable hypertension (resting RR: \>180/\>110 mmHg)
  • severely restricted lung function (FEV1 \<60%)
  • unstable Diabetes mellitus
  • severe orthopedic disease/restriction
  • acute / chronic infectious diseases
  • Electronic implants (defibrillator, pacemaker)
  • Persons in mental hospitals by order of authorities or jurisdiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg

Erlangen, 91052, Germany

RECRUITING

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dejan Reljic, Dr.

    University Erlangen Nuremberg Medical School

    PRINCIPAL INVESTIGATOR

  • Yurdaguel Zopf, Prof.

    University Erlangen Nuremberg Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dejan Reljic, Dr.

CONTACT

+49 9131 8545218dejan.reljic@uk-erlangen.de

Yurdaguel Zopf, Prof.

CONTACT

+49 9131 8545218yurdaguel.zopf@uk-erlangen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2019

First Posted

August 22, 2019

Study Start

May 1, 2019

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

August 22, 2019

Record last verified: 2019-08

Locations

DE(1)