- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05777941
Styrketrening med eksentrisk arm-cranking hos para-atleter (KREHA-ParAth)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Canton of Lucerne
-
Nottwil, Canton of Lucerne, Sveits, 6207
- Swiss Paraplegic Centre
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Upper body Performance
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Endurance Oxygen consumption
Tidsramme: 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
|
|
Maximal Workload
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 Index
Tidsramme: 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 Slope
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
|
Upper Arm Circumference
Tidsramme: 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
|
|
Lower Arm Circumference
Tidsramme: through study completion, an average of 20 weeks
|
Circumference of the lower arm is measured with measuring tape |
through study completion, an average of 20 weeks
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Fabian Ammann, MSc, SPZ
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2022-06
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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