NCT05777941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2024

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

March 8, 2023

Last Update Submit

March 16, 2026

Conditions

Keywords

eccentricstrength training

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Endurance Oxygen consumption

    through study completion, an average of 20 weeks

  • Maximal Workload

    through study completion, an average of 20 weeks

  • Upper body Mean Power

    through study completion, an average of 20 weeks

  • Upper body Power - Time to Peak

    through study completion, an average of 20 weeks

  • Upper body Fatigue Index

    through study completion, an average of 20 weeks

  • +5 more secondary outcomes

Study Arms (1)

Eccentric Training

EXPERIMENTAL

This Group will train on the KREHA for 20 Trainings

Other: eccentric arm-cranking training

Interventions

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.

Eccentric Training

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • findings during anamnesis of study physician
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Fabian Ammann, MSc

    SPZ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2023

First Posted

March 21, 2023

Study Start

December 1, 2022

Primary Completion

September 20, 2024

Study Completion

September 20, 2024

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations