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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05777941
Other study ID # 2022-06
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date May 30, 2024

Study information

Verified date March 2023
Source Swiss Paraplegic Research, Nottwil
Contact Fabian Ammann, MSc
Phone +4941419396624
Email fabian.ammann@sportmedizin-nottwil.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The new training device, the eccentric arm-crank, will be examined for its training effects in athletes with a spinal cord injury (SCI) by this project. That the training device can be used in 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 athletes with SCI are first tested for their upper body performance, followed by a training phase over 20 trainings and at the end the performance data is collected again. The training intensity and duration is continuously increased during the training phase.


Description:

At the beginning, the study design includes a 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) 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 45 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 14
Est. completion date May 30, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - male or female with traumatic or disease-related SCI - age between 18 and 50 years - experience in strength training - Squad status or at least 4h per week training - Biceps/triceps function - healthy(study physician) - adequately informed and confirmed per signature Exclusion Criteria: - findings during anamnesis of study physician - pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
eccentric arm-cranking training
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.

Locations

Country Name City State
Switzerland Swiss Paraplegic Centre Nottwil Lucerne

Sponsors (1)

Lead Sponsor Collaborator
Swiss Paraplegic Research, Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Upper body Performance Peak Power - maximal reached power, generated during the 30sec Wingate arm-crank test through study completion, an average of 20 weeks
Secondary Endurance Oxygen consumption VO2peak [ml/min/kg] - Basic Endurance test (Ergospirometry, arm-crank) through study completion, an average of 20 weeks
Secondary Maximal Workload Wmax [W] - Basic Endurance test (Ergospirometry, arm-crank) through study completion, an average of 20 weeks
Secondary Upper body Mean Power Mean Power [W] - Wingate Test (arm-crank) through study completion, an average of 20 weeks
Secondary Upper body Power - Time to Peak Time to Peak [s] - Wingate Test (arm-crank) through study completion, an average of 20 weeks
Secondary Upper body Fatigue Index Fatigue Index [%]- Wingate Test (arm-crank) through study completion, an average of 20 weeks
Secondary Upper body Fatigue Slope Fatigue Slope [W/s] - Wingate Test (arm-crank) through study completion, an average of 20 weeks
Secondary 1RM bench press One Repetition Maximum (1RM) [kg]- bench press through study completion, an average of 20 weeks
Secondary Grip Strength Maximal Force that can be generated by pressing hand towards a fist [N] through study completion, an average of 20 weeks
Secondary Upper Arm Circumference Circumference of the upper arm is measured with measuring tape through study completion, an average of 20 weeks
Secondary Lower Arm Circumference Circumference of the lower arm is measured with measuring tape through study completion, an average of 20 weeks
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