- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05156411
Strength Training With Eccentric Arm-cranking (KREHA)
August 23, 2022 updated by: Swiss Paraplegic Centre Nottwil
The new training device, the eccentric arm-crank, will be examined for its training effect by this project.
That the training device can be used in athletes and patients with paraplegia in the future, the so-called "testing of the applicability of this concept" will be carried out during this study.
Fourteen volunteer, healthy and trained people are first tested for their upper body performance, followed by a training phase over 20 trainings and at the and the performance data is collected again.
The training intensity and duration is continuously increased during the training phase.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
At the beginning, the study design includes an familiarisation appointment with performance tests and training on the eccentric arm-crank device (KREHA).
At least one week later, the first test sequence including a maximum strength test (bench press), magnetic resonance imaging (MRI) to determine the muscle cross-section area of the upper arm and a test to determine the anaerobic performance (Wingate test) is conducted.
The second test sequence takes place one to three days later.
This includes a handgrip strength test, an aerobic endurance test (ramp test on the arm crank ergometer with ergospirometry) and a further familiarisation training on the KREHA.
The training phase starts within two weeks after the pre-tests have been completed.
There are two to a maximum of three trainings per week.
These take 30 to 60 minutes and take place on the KREHA device under the supervision of the study staff.
The training phase lasts a maximum of twelve weeks (20 training sessions).
The first test sequence is repeated five to eight days after the last workout.
The second test sequence takes place at the same time interval as in the pre-tests.
Study Type
Interventional
Enrollment (Actual)
14
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
-
-
Lucerne
-
Nottwil, Lucerne, Switzerland, 6207
- Swiss Paraplegic Centre
-
-
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 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- male or female
- age between 18 and 50 years
- experience in strength training
- trained (minimum two times a week)
- healthy
- adequately informed and confirmed per signature
Exclusion Criteria:
- findings during anamnesis of study doctor
- pregnancy
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Eccentric Training
This Group will train on the KREHA for 20 Trainings
|
Over the twenty training sessions, able-bodied participants will exercise on the KREHA device.
An arm-crank has to be decelerated, which will be rotated by a prematurely defined revolution rate and training duration.
During this intervention a certain power has to be applied.
During the whole time of training a continous progression in power and training duration is applied
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Upper body Performance
Time Frame: through study completion, an average of 20 weeks
|
Peak Power - maximal reached power, generated during the 30sec Wingate arm-crank test
|
through study completion, an average of 20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endurance Oxygen consumption
Time Frame: through study completion, an average of 20 weeks
|
VO2peak [ml/min/kg] - Basic Endurance test (Ergospirometry, arm-crank)
|
through study completion, an average of 20 weeks
|
|
Endurance Power
Time Frame: through study completion, an average of 20 weeks
|
Wmax [W] - Basic Endurance test (Ergospirometry, arm-crank)
|
through study completion, an average of 20 weeks
|
|
Upper body Mean Power
Time Frame: through study completion, an average of 20 weeks
|
Mean Power [W] - Wingate Test (arm-crank)
|
through study completion, an average of 20 weeks
|
|
Upper body Power - Time to Peak
Time Frame: through study completion, an average of 20 weeks
|
Time to Peak [s] - Wingate Test (arm-crank)
|
through study completion, an average of 20 weeks
|
|
Upper body Fatigue resistance
Time Frame: through study completion, an average of 20 weeks
|
Fatigue Index [%]- Wingate Test (arm-crank)
|
through study completion, an average of 20 weeks
|
|
Upper body Fatigue resistance
Time Frame: through study completion, an average of 20 weeks
|
Fatigue Slope [W/s] - Wingate Test (arm-crank)
|
through study completion, an average of 20 weeks
|
|
1RM bench press
Time Frame: through study completion, an average of 20 weeks
|
One Repetition Maximum (1RM) [kg]- bench press
|
through study completion, an average of 20 weeks
|
|
Grip Strength
Time Frame: through study completion, an average of 20 weeks
|
Maximal Force that can be generated by pressing hand towards a fist [N]
|
through study completion, an average of 20 weeks
|
|
Cross sectional muscle area
Time Frame: through study completion, an average of 20 weeks
|
Cross sectional area of the upper arm is measured with MRI
|
through study completion, an average of 20 weeks
|
|
Upper Arm Circumference
Time Frame: through study completion, an average of 20 weeks
|
Circumference of the upper arm is measured with measuring tape
|
through study completion, an average of 20 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)
July 1, 2021
Primary Completion (Actual)
February 15, 2022
Study Completion (Actual)
March 1, 2022
Study Registration Dates
First Submitted
November 8, 2021
First Submitted That Met QC Criteria
December 1, 2021
First Posted (Actual)
December 14, 2021
Study Record Updates
Last Update Posted (Actual)
August 24, 2022
Last Update Submitted That Met QC Criteria
August 23, 2022
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2020-26 (DSR)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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