Mini-trampoline Intervention vs. Nordic Walking: Balance, Fitness and Neuropsychological Effects (TraWaFit)

November 13, 2020 updated by: Arno Schmidt-Trucksäss

Comparison of 12-week Mini-trampoline Intervention With a Nordic Walking Intervention: Balance, Fitness and Neuropsychological Effects

The effects of mini-trampoline training on balance, cardiorespiratory fitness, strength and neuropsychological parameters in an overweight or obese population are unknown. The aim of this 2-arm randomized controlled trial is to compare the effects of a 12-week mini-trampoline training and a 12-week nordic walking training on balance, fitness and strength in overweight/obese individuals.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A growing body of literature suggests, that obesity is not only associated with medical conditions such as diabetes, but also linked to altered gait, impaired balance and a greater likelihood of falls. Weight reduction has been shown to improve balance controle. Methods to increase physical activity are largely not accepted in this population and those which conserve the musculoskeletal system are rare. Physical activity has been shown to influence mood, quality of life and eating behavior. Mini-trampoline training has been shown to enhance stability and increase fitness.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4052
        • University of Basel, Department of Sport, Exercise and Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-55 years
  • Body Mass Index ≥25 kg/m2
  • ≤ 1h regular exercise/ physical activity per week

Exclusion Criteria:

  • cardiovascular or other chronic diseases not permitting sports participation
  • inability to follow the procedures of the study (e.g. due to dementia)
  • neurological disorders limiting balance or medications impairing balance
  • hypertensive blood pressure not permitting exercise (>180/100 mmHg)
  • medication: beta-blocking agents which reduce cardiac adaption abilities to exercise
  • known pregnancy with contraindications for exercise according to the guidelines of the American College of Obstetricians and Gynecologists

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mini-trampoline
participants allocated to this group will participate in a 12-week mini-trampoline group instructed training twice a week.
Other: mini-trampoline
Intervention period lasts 12 weeks, training is group instructed, twice weekly. Training sessions are one hour each. The training intensity of the two interventional arms is comparable. The training progression is defined in advance.
Active Comparator: Nordic Walking
participants allocated to this group will participate in a 12-week Nordic Walking group instructed training twice a week.
Other: Nordic Walking
Intervention period lasts 12 weeks, training is group instructed, twice weekly. Training sessions are one hour each. The training intensity of the two interventional arms is comparable. The training progression is defined in advance.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postural sway
Time Frame: assessed twice: before and after the intervention (12 weeks)
COPspeed (Center of pressure speed measured on a force plate in cm/sec) measured on a force plate in quiet stance with eyes closed
assessed twice: before and after the intervention (12 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
peak oxygen uptake
Time Frame: assessed twice: before and after the intervention (12 weeks)
(VO2 peak in ml/kg/min)
assessed twice: before and after the intervention (12 weeks)
submaximal heart rate at 50 Watts
Time Frame: assessed twice: before and after the intervention (12 weeks)
(HR at 50 Watts in beats/min)
assessed twice: before and after the intervention (12 weeks)
maximal work
Time Frame: assessed twice: before and after the intervention (12 weeks)
(Watts on bicycle ergometer)
assessed twice: before and after the intervention (12 weeks)
dynamic core strength
Time Frame: assessed twice: before and after the intervention (12 weeks)
(Nm/kg on dynamometer)
assessed twice: before and after the intervention (12 weeks)
lower body explosive strength
Time Frame: assessed twice: before and after the intervention (12 weeks)
(seconds on chair rise test)
assessed twice: before and after the intervention (12 weeks)
lower body functional endurance
Time Frame: assessed twice: before and after the intervention (12 weeks)
(repetitions during 30-second-chair rise test)
assessed twice: before and after the intervention (12 weeks)
isokinetic plantar flexion strength
Time Frame: assessed twice: before and after the intervention (12 weeks)
(Nm/kg on dynamometer)
assessed twice: before and after the intervention (12 weeks)
functional balance
Time Frame: assessed twice: before and after the intervention (12 weeks)
(cm in reach test)
assessed twice: before and after the intervention (12 weeks)
body fat mass
Time Frame: assessed twice: before and after the intervention (12 weeks)
(in kg)
assessed twice: before and after the intervention (12 weeks)
waist circumference
Time Frame: assessed twice: before and after the intervention (12 weeks)
(in cm)
assessed twice: before and after the intervention (12 weeks)
motivation and barriers
Time Frame: assessed twice: before and after the intervention (12 weeks)
(score on questionnaire)
assessed twice: before and after the intervention (12 weeks)
mood
Time Frame: assessed twice: before and after the intervention (12 weeks)
(score on multidimensional mood questionnaire)
assessed twice: before and after the intervention (12 weeks)
weight adjusted quality of life
Time Frame: assessed twice: before and after the intervention (12 weeks)
(score on IWQOL questionnaire)
assessed twice: before and after the intervention (12 weeks)
body dissatisfaction
Time Frame: assessed twice: before and after the intervention (12 weeks)
(score on Figure Rating Scale)
assessed twice: before and after the intervention (12 weeks)
eating behavior
Time Frame: assessed twice: before and after the intervention (12 weeks)
(score on FEV questionnaire)
assessed twice: before and after the intervention (12 weeks)
attention
Time Frame: assessed twice: before and after the intervention (12 weeks)
(score on the digit span test)
assessed twice: before and after the intervention (12 weeks)
cognitive flexibility
Time Frame: assessed twice: before and after the intervention (12 weeks)
(seconds during the Trail making test)
assessed twice: before and after the intervention (12 weeks)
executive planning function
Time Frame: assessed twice: before and after the intervention (12 weeks)
(score in the Tower of London Test (computer based version))
assessed twice: before and after the intervention (12 weeks)
behavioral shift and inhibition
Time Frame: assessed twice: before and after the intervention (12 weeks)
(number of mistakes in the Inhib Test (computer based version))
assessed twice: before and after the intervention (12 weeks)
body muscle mass
Time Frame: assessed twice: before and after the intervention (12 weeks)
(in kg)
assessed twice: before and after the intervention (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arno Schmidt-Trucksäss

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EKNZ 2015-231/232

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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