Peripheral Artery DiseaseNCT04043546
Observational Feasibility Study of Home-based Training With Therabands in PAD-patients
A study testing aerobic+resistance exercise training program in people with Peripheral Artery Disease and Intermittent Claudication, run by KU Leuven at 1 site in Belgium.
Trial summary
The study is an observational feasibility study to evaluate the feasibility of a combined aerobic+resistance training program in patients with IC. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Peripheral Artery Disease, Intermittent Claudication
- What is being tested?
- aerobic+resistance exercise training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2017to 30 Sep 2018
- Phase
- Interventional
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 50 yrs;
- ankle-brachial index (ABI) ≤ 0.9 in one or two legs;
- Fontaine stage II (Rutherford I 1-3) of PAD (new onset or conservatively treated);
- body mass index <35 kg/m 2 ;
- resting systolic blood pressure (BP) <160 mmHg and diastolic BP <105 mmHg;
- ability to walk at least 2 min at 2.0 mph;
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- ability to undertake an incremental treadmill test;
- decrease of at least 15% in ABI after a maximal treadmill test;
- not currently engaging in any regular exercise program.
Who cannot join
- exercise induced signs of myocardial ischemia or complex ventricular arrhythmias;
- no access to laptop or internet;
- no medical clearance for exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Feasability Study of Home-based Training With Therabands in PAD-patients - Addressing the Uncertainty of Acceptance, Satisfaction and Usability of a Home-based, Tele-monitored Program Combining Aerobic and Resistance Components in PAD-patients.
The study is an observational feasibility study to evaluate the feasibility of a combined aerobic+resistance training program in patients with IC.
- Being tested
- aerobic+resistance exercise training program
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic+resistance exercise training programBehavioural
Personalized exercise program based on the inclusion testing and patient screening will be provided to the patient. The program will consist of a gradual walking program as well as a gradual resistance training program using therabands.
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Experimental | Not described Receives: Behavioral: aerobic+resistance exercise training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
user satisfaction
self-developed questionnaire based evaluation of user satisfaction
Measured: 4 weeks
walking distance
pain free and maximal walking distance are recorded using the Gardner treadmill protocol.
Measured: 4 weeks
Secondary outcomes (1)
Physical activity
Physical activity, defined total active energy expenditure (kcal) is obtained from objective measurement of physical activity during 7 consecutive days using the Sensewear device.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start1 Oct 2017
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients enrolled in the study receive a novel physiotherapy program.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roselien Buys, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043546
- Sponsor's protocol ID
- PAD-feasibility
- Status last verified
- Aug 2019
- First submitted
- 10 Jul 2018
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cornelis N, Buys R, Dewit T, Benoit D, Claes J, Fourneau I, Cornelissen V. Satisfaction and Acceptability of Telemonitored Home-Based Exercise in Patients With Intermittent Claudication: Pragmatic Observational Pilot Study. JMIR Rehabil Assist Technol. 2021 Mar 22;8(1):e18739. doi: 10.2196/18739.
PubMed 33749616
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Feasability Study of Home-based Training With Therabands in PAD-patients - Addressing the Uncertainty of Acceptance, Satisfaction and Usability of a Home-based, Tele-monitored Program Combining Aerobic and Resistance Components in PAD-patients.
- ClinicalTrials.gov ID
- NCT04043546
- Acronym / sponsor ID
- PAD-feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 2 Aug 2019 (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.
The study is an observational feasibility study to evaluate the feasibility of a combined aerobic+resistance training program in patients with IC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients enrolled in the study receive a novel physiotherapy program.
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Experimental | Behavioral: aerobic+resistance exercise training program |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- age ≥ 50 yrs;
- ankle-brachial index (ABI) ≤ 0.9 in one or two legs;
- Fontaine stage II (Rutherford I 1-3) of PAD (new onset or conservatively treated);
- body mass index <35 kg/m 2 ;
- resting systolic blood pressure (BP) <160 mmHg and diastolic BP <105 mmHg;
Key exclusion criteria (3 listed)
- exercise induced signs of myocardial ischemia or complex ventricular arrhythmias;
- no access to laptop or internet;
- no medical clearance for exercise
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 |
|---|---|---|
| aerobic+resistance exercise training programPersonalized exercise program based on the inclusion testing and patient screening will be provided to the patient. The program will consist of a gradual walking program as well as a gradual resistance training program using therabands. | Behavioural | Exercise intervention |
Primary outcome
user satisfaction
Time frame: 4 weeks
self-developed questionnaire based evaluation of user satisfaction
walking distance
Time frame: 4 weeks
pain free and maximal walking distance are recorded using the Gardner treadmill protocol.
1 secondary outcome
Physical activity
Time frame: 2 months
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 2 Aug 2019.
- Derived from this study: PubMed 33749616Cornelis N, Buys R, Dewit T, Benoit D, Claes J, Fourneau I, Cornelissen V. Satisfaction and Acceptability of Telemonitored Home-Based Exercise in Patients With Intermittent Claudication: Pragmatic Observational Pilot Study. JMIR Rehabil Assist Technol. 2021 Mar 22;8(1):e18739. doi: 10.2196/18739.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic+resistance exercise training program in people with Peripheral Artery Disease and Intermittent Claudication, run by KU Leuven at 1 site in Belgium.
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 9 inclusion and 3 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 2 Aug 2019. 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 Belgium. 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?
user satisfaction (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04043546, which also lists 1 linked publication.
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 2 Aug 2019.