HealthyFit15NCT02746692
Faster Back Home: Efficacy of a High-intensity Endurance Training
A study testing Fit15 and Endurance in people with Healthy, run by Goethe University at 1 site in Germany.
Trial summary
Sports medical experts recommend considerable amounts of regular physical activity in order to improve strength, motor control, endurance and flexibility. However, only a small share of the population is able to meets the corresponding international guidelines. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fit15 and Endurance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy
- subscribing informed consent
Who cannot join
- Drug intake in the past 48 hours
- Pregnancy
- Muscle soreness
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Sports Medicine, Goethe University Frankfurt/Main
Frankfurt am Main, Hesse, 60487
About this study
Official title: Faster Back Home: a Randomized Controlled Equivalence Study on the Efficacy of a High-intensity 15 Minute Aerobic Endurance Training
Sports medical experts recommend considerable amounts of regular physical activity in order to improve strength, motor control, endurance and flexibility. However, only a small share of the population is able to meets the corresponding international guidelines. One reason for this is supposed to consist in private scheduling problems and the high time expenditure. Against this background, high-intensity intermittent training methods with short durations have become popular.
The present study aims to evaluate the effectivity of a high -intensity functional circuit training (the FIT15 program) in improving body function.
Thirty healthy individuals will be included in the randomized, controlled two-armed parallel group trial. In the intervention group, the participants will perform the FIT15 program, a group-based high-intensity circuit training based on functional movement patterns (e.g. squats, push-ups, burpees, jumps, rope-skipping). The training will be carried out three times a week, each 15 minutes for a total of six weeks. In the control group, the participants will exercise three times a week (in total for six weeks) at moderate intensity on an ergometer according to the cardiopulmonary exercise guidelines of the American College of Sports Medicine. Outcomes assess prior and following the six-week training period encompass body fat and muscle mass (bio impedance analysis), aerobic exercise capacity (spirometric exercise testing including lactate analysis), postural control (force plate), maximum strength of the leg extensors and shoulder muscles (1 repetition maximum) and psychometric variables (e.g. physical activity readiness questionnaire).
- Conditions
- Healthy
- Being tested
- Fit15, Endurance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit15Other
Group-based high-intensity circuit training based on functional movement patterns (e.g. squats, push-ups, burpees, jumps, ropeskipping).
Total duration 15 minutes circle training: 20s workout, 10 rest
EnduranceOther
Moderate intensity ergometer training. Total duration 50 minutes
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Fit15 |
| Comparison | Active comparator | Not described Receives: Other: Endurance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal ventilatory aerobic endurance capacity assessed by spiroergometry
Measured: 10 min.
Maximal lactate aerobic endurance capacity assessed by spiroergometry
Measured: 10 min.
Secondary outcomes (6)
Jumping performance; counter movement jump
Measured: 1 min.
Dynamic balance assessed with the time to stabilization test
Measured: 2 min
Static balance assessed with the time to stabilization test
Measured: 2 min
Maximal isometric voluntary force of the shoulder muscles
Measured: 10 min
Maximal isometric voluntary force of the lower limb extensors
Measured: 10 min
body composition assessed with a external non-invasive impedance device
Measured: 10 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Dr. Winfried Banzer, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746692
- Sponsor's protocol ID
- SpM2016-003
- Acronym
- Fit15
- Status last verified
- Nov 2017
- First submitted
- 18 Apr 2016
- Last updated
- 30 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faster Back Home: a Randomized Controlled Equivalence Study on the Efficacy of a High-intensity 15 Minute Aerobic Endurance Training
- ClinicalTrials.gov ID
- NCT02746692
- Acronym / sponsor ID
- Fit15 / SpM2016-003
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sports medical experts recommend considerable amounts of regular physical activity in order to improve strength, motor control, endurance and flexibility. However, only a small share of the population is able to meets the corresponding international guidelines. One reason for this is supposed to consist in private scheduling problems and the high time expenditure. Against this background, high-intensity intermittent training methods with short durations have become popular.
The present study aims to evaluate the effectivity of a high -intensity functional circuit training (the FIT15 program) in improving body function.
Thirty healthy individuals will be included in the randomized, controlled two-armed parallel group trial. In the intervention group, the participants will perform the FIT15 program, a group-based high-intensity circuit training based on functional movement patterns (e.g. squats, push-ups, burpees, jumps, rope-skipping). The training will be carried out three times a week, each 15 minutes for a total of six weeks. In the control group, the participants will exercise three times a week (in total for six weeks) at moderate intensity on an ergometer according to the cardiopulmonary exercise guidelines of the American College of Sports Medicine. Outcomes assess prior and following the six-week training period encompass body fat and muscle mass (bio impedance analysis), aerobic exercise capacity (spirometric exercise testing including lactate analysis), postural control (force plate), maximum strength of the leg extensors and shoulder muscles (1 repetition maximum) and psychometric variables (e.g. physical activity readiness questionnaire).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Fit15 |
| Comparison | Active comparator | Other: Endurance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy
- subscribing informed consent
Key exclusion criteria (3 listed)
- Drug intake in the past 48 hours
- Pregnancy
- Muscle soreness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fit15Group-based high-intensity circuit training based on functional movement patterns (e.g. squats, push-ups, burpees, jumps, ropeskipping). Total duration 15 minutes circle training: 20s workout, 10 rest | Other | Intervention |
| EnduranceModerate intensity ergometer training. Total duration 50 minutes | Other | Comparison |
Primary outcome
Maximal ventilatory aerobic endurance capacity assessed by spiroergometry
Time frame: 10 min.
Maximal lactate aerobic endurance capacity assessed by spiroergometry
Time frame: 10 min.
6 secondary outcomes
Jumping performance; counter movement jump
Time frame: 1 min.
Dynamic balance assessed with the time to stabilization test
Time frame: 2 min
Static balance assessed with the time to stabilization test
Time frame: 2 min
Maximal isometric voluntary force of the shoulder muscles
Time frame: 10 min
Maximal isometric voluntary force of the lower limb extensors
Time frame: 10 min
body composition assessed with a external non-invasive impedance device
Time frame: 10 min.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fit15 and Endurance in people with Healthy, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal ventilatory aerobic endurance capacity assessed by spiroergometry (time frame: 10 min.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.