OverweightTraWaFitNCT02596152
Mini-trampoline Intervention vs. Nordic Walking: Balance, Fitness and Neuropsychological Effects
A study testing mini-trampoline and Nordic Walking in people with Overweight and Obesity, run by Arno Schmidt-Trucksäss at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- mini-trampoline and Nordic Walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2015to Sep 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-55 years
- Body Mass Index ≥25 kg/m2
- ≤ 1h regular exercise/ physical activity per week
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Basel, Department of Sport, Exercise and Health
Basel, 4052
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight, Obesity
- Being tested
- mini-trampoline, Nordic Walking
- Keywords
- balance, strength, barriers towards exercise, quality of life, body dissatisfaction, executive functions, eating behavior, fitness
- Medical subject headings
- Overweight, Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mini-trampolineOther
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.
Nordic WalkingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mini-trampoline | Experimental | participants allocated to this group will participate in a 12-week mini-trampoline group instructed training twice a week. Receives: Other: mini-trampoline |
| Nordic Walking | Active comparator | participants allocated to this group will participate in a 12-week Nordic Walking group instructed training twice a week. Receives: Other: Nordic Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural sway
COPspeed (Center of pressure speed measured on a force plate in cm/sec) measured on a force plate in quiet stance with eyes closed
Measured: assessed twice: before and after the intervention (12 weeks)
Secondary outcomes (20)
peak oxygen uptake
(VO2 peak in ml/kg/min)
Measured: assessed twice: before and after the intervention (12 weeks)
submaximal heart rate at 50 Watts
(HR at 50 Watts in beats/min)
Measured: assessed twice: before and after the intervention (12 weeks)
maximal work
(Watts on bicycle ergometer)
Measured: assessed twice: before and after the intervention (12 weeks)
dynamic core strength
(Nm/kg on dynamometer)
Measured: assessed twice: before and after the intervention (12 weeks)
lower body explosive strength
(seconds on chair rise test)
Measured: assessed twice: before and after the intervention (12 weeks)
lower body functional endurance
(repetitions during 30-second-chair rise test)
Measured: assessed twice: before and after the intervention (12 weeks)
isokinetic plantar flexion strength
(Nm/kg on dynamometer)
Measured: assessed twice: before and after the intervention (12 weeks)
functional balance
(cm in reach test)
Measured: assessed twice: before and after the intervention (12 weeks)
body fat mass
(in kg)
Measured: assessed twice: before and after the intervention (12 weeks)
waist circumference
(in cm)
Measured: assessed twice: before and after the intervention (12 weeks)
motivation and barriers
(score on questionnaire)
Measured: assessed twice: before and after the intervention (12 weeks)
mood
(score on multidimensional mood questionnaire)
Measured: assessed twice: before and after the intervention (12 weeks)
weight adjusted quality of life
(score on IWQOL questionnaire)
Measured: assessed twice: before and after the intervention (12 weeks)
body dissatisfaction
(score on Figure Rating Scale)
Measured: assessed twice: before and after the intervention (12 weeks)
eating behavior
(score on FEV questionnaire)
Measured: assessed twice: before and after the intervention (12 weeks)
attention
(score on the digit span test)
Measured: assessed twice: before and after the intervention (12 weeks)
cognitive flexibility
(seconds during the Trail making test)
Measured: assessed twice: before and after the intervention (12 weeks)
executive planning function
(score in the Tower of London Test (computer based version))
Measured: assessed twice: before and after the intervention (12 weeks)
behavioral shift and inhibition
(number of mistakes in the Inhib Test (computer based version))
Measured: assessed twice: before and after the intervention (12 weeks)
body muscle mass
(in kg)
Measured: assessed twice: before and after the intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arno Schmidt-Trucksäss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Arno Schmidt-Trucksäss, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596152
- Sponsor's protocol ID
- EKNZ 2015-231/232
- Acronym
- TraWaFit
- Status last verified
- Nov 2020
- First submitted
- 30 Oct 2015
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 12-week Mini-trampoline Intervention With a Nordic Walking Intervention: Balance, Fitness and Neuropsychological Effects
- ClinicalTrials.gov ID
- NCT02596152
- Acronym / sponsor ID
- TraWaFit / EKNZ 2015-231/232
- Conditions
- Overweight, Obesity
- Keywords
- balance, strength, barriers towards exercise, quality of life, body dissatisfaction, executive functions, eating behavior, fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Arno Schmidt-TrucksässUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 4 Nov 2015 (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.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini-trampoline | Experimental | Other: mini-trampolineparticipants allocated to this group will participate in a 12-week mini-trampoline group instructed training twice a week. |
| Nordic Walking | Active comparator | Other: Nordic Walkingparticipants allocated to this group will participate in a 12-week Nordic Walking group instructed training twice a week. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-55 years
- Body Mass Index ≥25 kg/m2
- ≤ 1h regular exercise/ physical activity per week
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| mini-trampolineIntervention 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. | Other | Mini-trampoline |
| Nordic WalkingIntervention 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. | Other | Nordic Walking |
Primary outcome
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
20 secondary outcomes
peak oxygen uptake
Time frame: 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)
maximal work
Time frame: assessed twice: before and after the intervention (12 weeks)
dynamic core strength
Time frame: assessed twice: before and after the intervention (12 weeks)
lower body explosive strength
Time frame: assessed twice: before and after the intervention (12 weeks)
lower body functional endurance
Time frame: assessed twice: before and after the intervention (12 weeks)
isokinetic plantar flexion strength
Time frame: assessed twice: before and after the intervention (12 weeks)
functional balance
Time frame: assessed twice: before and after the intervention (12 weeks)
body fat mass
Time frame: assessed twice: before and after the intervention (12 weeks)
waist circumference
Time frame: assessed twice: before and after the intervention (12 weeks)
motivation and barriers
Time frame: assessed twice: before and after the intervention (12 weeks)
mood
Time frame: 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)
body dissatisfaction
Time frame: assessed twice: before and after the intervention (12 weeks)
eating behavior
Time frame: assessed twice: before and after the intervention (12 weeks)
attention
Time frame: assessed twice: before and after the intervention (12 weeks)
cognitive flexibility
Time frame: assessed twice: before and after the intervention (12 weeks)
executive planning function
Time frame: assessed twice: before and after the intervention (12 weeks)
behavioral shift and inhibition
Time frame: assessed twice: before and after the intervention (12 weeks)
body muscle mass
Time frame: assessed twice: before and after the intervention (12 weeks)
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 16 Nov 2020.
Related trials for Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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 mini-trampoline and Nordic Walking in people with Overweight and Obesity, run by Arno Schmidt-Trucksäss at 1 site in Switzerland.
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 3 inclusion and 6 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 16 Nov 2020. 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 Switzerland. 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?
Postural sway (time frame: assessed twice: before and after the intervention (12 weeks)). 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 16 Nov 2020.