Physical ActivityNCT03405558
Performance Developement of Patients With Paraplegia During First Rehabilitation
An observational study of Physical Activity, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2018to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with a paraplegia during the first rehabilitation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: Effects of an Individually Tailored Endurance Training on the Performance Developement of Patients With Paraplegia During First Rehabilitation: an Observational Study
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.
- Conditions
- Physical Activity
- Being tested
- No intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak power
Maximal performance reached during incremental exercise on an arm-crank ergometer
Measured: 10min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Jan 2018
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Claudio Perret, Principal investigator, Swiss Paraplegic Research, Nottwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405558
- Sponsor's protocol ID
- 2017-01
- Status last verified
- Mar 2023
- First submitted
- 8 Jan 2018
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Individually Tailored Endurance Training on the Performance Developement of Patients With Paraplegia During First Rehabilitation: an Observational Study
- ClinicalTrials.gov ID
- NCT03405558
- Acronym / sponsor ID
- 2017-01
- Conditions
- Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with a paraplegia during the first rehabilitation
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionAs this is an observational study, we will only supervise testing and training sessions which were performed anyway during first rehabilitation as daily therapeutic routine | Other | – |
Primary outcome
Peak power
Time frame: 10min
Maximal performance reached during incremental exercise on an arm-crank ergometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Perret principal investigator
Swiss Paraplegic Research, Nottwil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Activity, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak power (time frame: 10min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.