Strength Training With Eccentric Arm-cranking in Para-athletes (KREHA-ParAth)
Primary Purpose
Spinal Cord Injuries
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
eccentric arm-cranking training
Sponsored by
About this trial
This is an interventional basic science trial for Spinal Cord Injuries focused on measuring eccentric, strength training
Eligibility Criteria
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
Sites / Locations
- Swiss Paraplegic CentreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Eccentric Training
Arm Description
This Group will train on the KREHA for 20 Trainings
Outcomes
Primary Outcome Measures
Upper body Performance
Peak Power - maximal reached power, generated during the 30sec Wingate arm-crank test
Secondary Outcome Measures
Endurance Oxygen consumption
VO2peak [ml/min/kg] - Basic Endurance test (Ergospirometry, arm-crank)
Maximal Workload
Wmax [W] - Basic Endurance test (Ergospirometry, arm-crank)
Upper body Mean Power
Mean Power [W] - Wingate Test (arm-crank)
Upper body Power - Time to Peak
Time to Peak [s] - Wingate Test (arm-crank)
Upper body Fatigue Index
Fatigue Index [%]- Wingate Test (arm-crank)
Upper body Fatigue Slope
Fatigue Slope [W/s] - Wingate Test (arm-crank)
1RM bench press
One Repetition Maximum (1RM) [kg]- bench press
Grip Strength
Maximal Force that can be generated by pressing hand towards a fist [N]
Upper Arm Circumference
Circumference of the upper arm is measured with measuring tape
Lower Arm Circumference
Circumference of the lower arm is measured with measuring tape
Full Information
NCT ID
NCT05777941
First Posted
March 8, 2023
Last Updated
March 8, 2023
Sponsor
Swiss Paraplegic Research, Nottwil
1. Study Identification
Unique Protocol Identification Number
NCT05777941
Brief Title
Strength Training With Eccentric Arm-cranking in Para-athletes
Acronym
KREHA-ParAth
Official Title
Strength Training With Eccentric Arm-cranking in Para-athletes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Paraplegic Research, Nottwil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
eccentric, strength training
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eccentric Training
Arm Type
Experimental
Arm Description
This Group will train on the KREHA for 20 Trainings
Intervention Type
Other
Intervention Name(s)
eccentric arm-cranking training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Upper body Performance
Description
Peak Power - maximal reached power, generated during the 30sec Wingate arm-crank test
Time Frame
through study completion, an average of 20 weeks
Secondary Outcome Measure Information:
Title
Endurance Oxygen consumption
Description
VO2peak [ml/min/kg] - Basic Endurance test (Ergospirometry, arm-crank)
Time Frame
through study completion, an average of 20 weeks
Title
Maximal Workload
Description
Wmax [W] - Basic Endurance test (Ergospirometry, arm-crank)
Time Frame
through study completion, an average of 20 weeks
Title
Upper body Mean Power
Description
Mean Power [W] - Wingate Test (arm-crank)
Time Frame
through study completion, an average of 20 weeks
Title
Upper body Power - Time to Peak
Description
Time to Peak [s] - Wingate Test (arm-crank)
Time Frame
through study completion, an average of 20 weeks
Title
Upper body Fatigue Index
Description
Fatigue Index [%]- Wingate Test (arm-crank)
Time Frame
through study completion, an average of 20 weeks
Title
Upper body Fatigue Slope
Description
Fatigue Slope [W/s] - Wingate Test (arm-crank)
Time Frame
through study completion, an average of 20 weeks
Title
1RM bench press
Description
One Repetition Maximum (1RM) [kg]- bench press
Time Frame
through study completion, an average of 20 weeks
Title
Grip Strength
Description
Maximal Force that can be generated by pressing hand towards a fist [N]
Time Frame
through study completion, an average of 20 weeks
Title
Upper Arm Circumference
Description
Circumference of the upper arm is measured with measuring tape
Time Frame
through study completion, an average of 20 weeks
Title
Lower Arm Circumference
Description
Circumference of the lower arm is measured with measuring tape
Time Frame
through study completion, an average of 20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabian Ammann, MSc
Phone
+4941419396624
Email
fabian.ammann@sportmedizin-nottwil.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Claudio Perret, Dr. sc. nat
Phone
+41419396650
Email
claudio.perret@paraplegie.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabian Ammann, MSc
Organizational Affiliation
SPZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swiss Paraplegic Centre
City
Nottwil
State/Province
Lucerne
ZIP/Postal Code
6207
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabian Ammann, MSc
Phone
+41419396624
Email
fabian.ammann@sportmedizin-nottwil.ch
First Name & Middle Initial & Last Name & Degree
Claudio Perret, Dr. sc. nat
Phone
+41419396650
Email
claudio.perret@paraplegie.ch
First Name & Middle Initial & Last Name & Degree
Fabian Ammann, MSc
12. IPD Sharing Statement
Plan to Share IPD
No
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Strength Training With Eccentric Arm-cranking in Para-athletes
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