Abdominal SurgeryPhase 4NCT00819936
A Controlled Trial of Effectiveness of a Backward Walking Program in Patients Recovering From Abdominal Aorta Surgery
A Phase 4 study testing forward walking and backward walking in people with Abdominal Surgery, run by Medical University of Silesia.
Trial summary
Summary Question: Does backward walking offer additional therapeutic value in patients after aortic aneurysm surgery? Participants: The study of backward walking as an addictive physiotherapy procedure was conducted in the group of 65 patients who underwent abdominal aorta surgery. Read more about this study
- Who is it for?
- Ages 65 to 75 years, men only
- Conditions the study is for
- Abdominal Surgery
- What is being tested?
- forward walking and backward walking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Dec 2006
- Phase
- Phase 4
- 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 65 to 75 years
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with abdominal aortic aneurysm
- Age 65-75 years
- Male sex
- Stable cardiologic status
- Absence of neurological disorders
- Non-symptomatic aneurysm - non-ruptured
- No pain complaints
- No motion system impairments
Who cannot join
- Patients with neurological disorders
- Unstable coronary heart disease symptomatic aortic aneurysm - dissecans aneurysm
- Having difficulty in locomotion
- Having contradiction for starting physical training during the first or second day after surgery
- Patients with psychiatric disease
- Lack of patient's compliance with physiotherapist; AND
- Other medical contraindications
About this study
Official title: A Controlled Trial of Effectiveness of a Backward Walking Program in Patients Recovering From an Abdominal Aorta Surgery
Summary Question: Does backward walking offer additional therapeutic value in patients after aortic aneurysm surgery? Participants: The study of backward walking as an addictive physiotherapy procedure was conducted in the group of 65 patients who underwent abdominal aorta surgery. The patients were randomly divided into three subgroups and three various models of physiotherapy were applied. Control group has only routine physiotherapy since therapeutic group I and II have also walking exercises forward in group I and backward in group II respectively.
- Conditions
- Abdominal Surgery
- Being tested
- forward walking, backward walking
- Keywords
- abdominal aorta surgery, Physical Training, backward walking, physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
forward walkingProcedure or surgery
comparison forward walking vs backward walking in the physiotherapy after after abdominal surgery
backward walkingProcedure or surgery
physiotherapy with use a backward walking type of physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Backward walking, Receives: Procedure: backward walking |
| 1 | Active comparator | Forward walking Receives: Procedure: forward walking |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startJan 2005
- Primary completionDec 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal SurgeryStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819936
- Sponsor's protocol ID
- B.W 2008/A
- Status last verified
- Jan 2009
- First submitted
- 8 Jan 2009
- Last updated
- 9 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Trial of Effectiveness of a Backward Walking Program in Patients Recovering From an Abdominal Aorta Surgery
- ClinicalTrials.gov ID
- NCT00819936
- Acronym / sponsor ID
- B.W 2008/A
- Conditions
- Abdominal Surgery
- Keywords
- abdominal aorta surgery, Physical Training, backward walking, physiotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2006
- First posted
- 9 Jan 2009 (estimated)
- 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.
Summary Question: Does backward walking offer additional therapeutic value in patients after aortic aneurysm surgery? Participants: The study of backward walking as an addictive physiotherapy procedure was conducted in the group of 65 patients who underwent abdominal aorta surgery. The patients were randomly divided into three subgroups and three various models of physiotherapy were applied. Control group has only routine physiotherapy since therapeutic group I and II have also walking exercises forward in group I and backward in group II respectively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Procedure: backward walkingBackward walking, |
| 1 | Active comparator | Procedure: forward walkingForward walking |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Patients with abdominal aortic aneurysm
- Age 65-75 years
- Male sex
- Stable cardiologic status
- Absence of neurological disorders
Key exclusion criteria (7 listed)
- Patients with neurological disorders
- Unstable coronary heart disease symptomatic aortic aneurysm - dissecans aneurysm
- Having difficulty in locomotion
- Having contradiction for starting physical training during the first or second day after surgery
- Patients with psychiatric disease
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 |
|---|---|---|
| forward walkingcomparison forward walking vs backward walking in the physiotherapy after after abdominal surgery | Procedure or surgery | 1 |
| backward walkingphysiotherapy with use a backward walking type of physiotherapy | Procedure or surgery | 2 |
Primary outcome
Not reported in the source record.
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 9 Jan 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing forward walking and backward walking in people with Abdominal Surgery, run by Medical University of Silesia.
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 8 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 9 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 9 Jan 2009.