NCT03405558

Brief Summary

A high physical fitness is crucial for a good quality of life in persons suffering from a spinal cord injury. The aim of the present observational study is to investigate the influence of an individually tailored 8-week endurance training program on endurance performance of patients with a paraplegia during their first rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

5.1 years

First QC Date

January 8, 2018

Last Update Submit

March 10, 2023

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (1)

  • Peak power

    Maximal performance reached during incremental exercise on an arm-crank ergometer

    10min

Interventions

No interventionOTHER

As this is an observational study, we will only supervise testing and training sessions which were performed anyway during first rehabilitation as daily therapeutic routine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with a paraplegia during the first rehabilitation

You may qualify if:

  • Written informed consent
  • male or female, paraplegia (AIS A-C, lesion Level Th1-Th12)
  • Age 18-65 years
  • Manual wheelchair user
  • Patient during first rehabilitation

You may not qualify if:

  • BMI ≥ 30
  • unable to use an arm-crank Ergometer due to e.g. spasticity
  • physical impairment, which makes it impossible to perform an arm-crank ergometry
  • Progressive disease (g.g. tumor, MS)
  • Ventilator dependent
  • existing cardiopulmonary disease
  • Unstable medical situation

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

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Claudio Perret

    Swiss Paraplegic Research, Nottwil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 23, 2018

Study Start

January 1, 2018

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

March 13, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)