- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02596152
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
54
Phase
- 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
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-
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Basel, Switzerland, 4052
- University of Basel, Department of Sport, Exercise and Health
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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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Mini-trampoline
participants allocated to this group will participate in a 12-week mini-trampoline group instructed training twice a week.
|
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.
|
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
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
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
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)
August 1, 2015
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
October 30, 2015
First Submitted That Met QC Criteria
November 2, 2015
First Posted (Estimate)
November 4, 2015
Study Record Updates
Last Update Posted (Actual)
November 16, 2020
Last Update Submitted That Met QC Criteria
November 13, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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