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Training study to optimize training adaptions of endurance training through increasing intensity

Organizational Data

DRKS-ID:
DRKS00031445
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2023-03-08
Last update in DRKS:
2023-03-08
Registration type:
Retrospective

Acronym/abbreviation of the study

TRAIN

URL of the study

No Entry

Brief summary in lay language

This training study investigated the effects of 26 weeks of endurance training on cardiorespiratory fitness, with and without increasing training intensity. For this purpose, it was agroup based and individual response examined on a group level and on an individual level whether the endurance performance can be increased by increasing the intensity, if the energy consumption remains constant.

Brief summary in scientific language

In this work, cardiorespiratory fitness, established risk factors, and prognostic factors for cardiovascular disease of endurance training, were examined in the context of a longitudinal randomized training trial. For this purpose, two investigation questions were examined at the group -and individual-level. 1. Can cardiorespiratory fitness be increased by increasing training intensity for an energy-equivalent training stimulus? 2. Can a nonresponse rate be reduced or even eliminated through an increase in intensity with energy expenditure held constant?

Health condition or problem studied

Free text:
primary prevention; effect of physical activity in healthy subjects
Healthy volunteers:
Yes

Interventions, Observational Groups

Arm 1:
16 healthy, untrained adults trained for 26 weeks with moderate intensity (3 days per week, 50 minutes per session, training intensity 55HRreserve)
Arm 2:
16 healthy, untrained adults trained for 26 weeks with moderate intensity (3 days per week, 50 minutes per session, training intensity 55HRreserve). For 8 weeks at 70% HRreserve and then performed high-intensity interval training (4x4) for another 8 weeks.

Endpoints

Primary outcome:
Data were recorded three times at baseline, after 10 weeks, after 18 weeks and after 26 weeks of training. Cardiorespiratory fitness was measured by a) maximum oxygen uptake (VO2max), b) maximum running speed, c) running economy, d) submaximal heart rate, e) lactate kinetics. Measures were performed three times at baseline, after 10 weeks, 18 weeks and after 26 weeks of training. Testing procedures Three baseline exercise tests were performed for habituation and to assess day-to-day variability of V̇O2max. At basline all participants underwent a medical examination, blood sampling, resting and exercise electrocardiogram (ECG), and maximal cardiorespiratory exercise testing on a treadmill (type ELG 70, Woodway GmbH, Weil am Rhein, Germany). Before exercise testing, height and body weight were measured. Body fat percentage was assessed by a 10-site skinfold method with a Harpenden caliper. Resting heart rate (HRrest) and resting blood pressure (RRrest) were assessed in supine position after a ten minute resting period at the right and left arm. Gas exchange measurements were conducted continuously using a breath-by-breath system (MetaLyzer® 3B, Cortex Biophysik GmbH, Leipzig, Germany). Lactate samples were taken at rest, during each break between GXT stages, and during the post-exercise period (1st, 3rd, and 5th min) from the hyperaemised earlobe. An enzymatic-amperometric method was used to analyse the samples (Super GL, Rolf Greiner Biochemica, Flacht, Germany).
Secondary outcome:
Health related outcomes were measured by A) resting heart rate B) resting blood pressure C) body composition D) bloodmarkers (e.g. cholesterol). A, B, C, D were measured in both groups at baseline, after 10 weeks, 18 weeks and 26 weeks.

Study Design

Purpose:
Prevention
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
I
Study type:
Interventional
Mechanism of allocation concealment:
adaptiv stratified randomisation
Blinding:
No
Assignment:
Other
Sequence generation:
Stratification markers were age, gender and VO2max and response ton VO2max
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Institut für Sport- und Präventivmedizin Universität des Saarlandes Saarbrücken

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2020-01-05
Planned study completion date:
No Entry
Actual Study Completion Date:
2021-03-01
Target Sample Size:
55
Final Sample Size:
48

Inclusion Criteria

Sex:
All
Minimum Age:
30 Years
Maximum Age:
60 Years
Additional Inclusion Criteria:
1) healthy 2) nonsmokers 3) training status, within the last 6 months, no regular endurance training and no other training-effective activity > 1 h/week; strength training < 2 units/week 4) never competitive sports 5) VO2max Männer < 50 ml * kg-1*min-1; Frauen < 45 ml * kg-1*min-1

Exclusion Criteria

1) BMI > 30 kg•m-2 2) resting blood pressure (RRrest) ≥ 160/100 mmHg) 3) total cholesterol ≥ 300 mg•dl-1 4) maximum oxygen uptake (V̇O2max) > 50 ml•kg-1•min-1 for men; > 45 ml•kg-1•min-1 for women 5) iron deficiency (Ferritin ≤ 34 ng•ml-1) 6) thyroid dysfunction (TSH ≤ 0.34 mU•l-1; ≥ 4.0 ng•ml-1) 7) medications with potential influence on target parameters (e.g. beta-blockers) and pregnancy 8) Internal or orthopedic diseases for which maximum exertion or regular running training is contraindicated.

Addresses

Primary Sponsor

Institut für Sport- und Präventivmedizin Universität des Saarlandes
Prof. Dr. med. Tim Meyer
66123 Saarbrücken
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Institut für Sport- und Präventivmedizin Universität des Saarlandes
Prof. Dr. med. Tim Meyer
Campus, Geb. B8 2
66123 Saarbrücken
Germany
Telephone:
+49 681-302 70400
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Institut für Sport- und Präventivmedizin Universität des Saarlandes
Prof. Dr. med. Tim Meyer
Campus, Geb. B8 2
66123 Saarbrücken
Germany
Telephone:
+49 681-302 70400
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Institut für Sport- und Präventivmedizin Universität des Saarlandes
Prof. Dr. med. Tim Meyer
Campus, Geb. B8 2
66123 Saarbrücken
Germany
Telephone:
+49 681-302 70400
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Institut für Sport- und Präventivmedizin Universität des Saarlandes
66123 Saarbrücken
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Institutional budget, no external funding (budget of sponsor/PI)

Deutsche Hochschule für Prävention und Gesundheitsmanagement
66123 Saarbrücken
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission bei der Ärztekammer des Saarlandes
Faktoreistr. 4
66111 Saarbrücken
Germany
Telephone:
+49-681-4003216
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2019-09-25
Ethics committee number:
Ha 219/19
Vote of the Ethics Committee:
Approved
Date of the vote:
2019-10-17

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
The data is currently not available

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
2023
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
Baseline Characteristics + Flowchart
Brief summary of results:
No Entry