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Peripheral Arterial DiseaseNCT05961943

RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients

A study testing RESPONSE-2-PAD in people with Peripheral Arterial Disease and Sedentary Behavior, run by National Institute for Prevention and Cardiovascular Health, Ireland at 1 site in Ireland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The RESPONSE-2- peripheral arterial disease (PAD) program will be implemented to modify sedentary time in patients with PAD. It is an adapted version of the RESPONSE that aims to reduce sedentary behavior in individuals with diabetes. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RESPONSE-2-PAD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIreland
Study dates
29 Sep 2023to Aug 2025
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults (≥18 years),
  • Symptomatic patients with established peripheral arterial disease. PAD is confirmed by any of the following:
  • Ankle-brachial index (ABI) of less than 0.90 in at least one lower extremity
  • Toe brachial index of less than 0.60
  • Arterial occlusive disease in one lower extremity by duplex ultrasonography, computed tomographic angiography or magnetic resonance angiography.
  • Willing and able to give informed consent.
  • Can read and speak English.

Who cannot join

  • patients with significant PAD in the form of rest pain.
  • Any impairments that severely affect mobility (e.g., wheelchair bound).
  • Cognitive impairments revealed by medical records.
  • Significant comorbid disease that would significantly impair the ability to participate in activity.
  • Pregnant / lactating females.

Trial locations and contacts

1 site in 1 country.

Ireland1 site, 1 recruiting
  • National Institute for prevention and Cardiovascular Health

    Galway, H91 FF68

    NIPC Health, 0035391893299, Jennifer.jones@universityofgalway.ie

    Wael Tawfick, 0035391542376, wael.tawfick@hse.ie

    Recruiting

Other trials in Ireland

About this study

Official title: Feasibility, Acceptability, and Outcomes of the "RESPONSE-2" Program in Reducing Sedentary Behavior in Patients With Peripheral Arterial Disease: A Mixed Methods Pilot Study

The RESPONSE-2- peripheral arterial disease (PAD) program will be implemented to modify sedentary time in patients with PAD. It is an adapted version of the RESPONSE that aims to reduce sedentary behavior in individuals with diabetes. The RESPONSE-2-PAD is a multicomponent program involves an online educational component, sedentary reminders and health coaching sessions, which are designed to modify patients' sedentary behavior.

Read the detailed description

Peripheral arterial disease (PAD) affects more than 230 million patients globally. PAD is characterized by a reduction in arterial perfusion caused by atherosclerotic plaque. PAD can negatively impact a person's quality of life due to the functional limitations caused by symptoms and the possibility of losing limbs. It also increases the risk of major adverse cardiac events (MACE). Many risk factors have been identified for PAD. Recently, sedentary behavior (SB) has emerged as an important risk factor for cardiovascular disease (CVD) including PAD independent to physical activity.

Studies have reported that patients with PAD have significantly higher levels of total sedentary time (ST) compared to those without PAD. Consequently, early intervention and management strategies, including addressing sedentary behavior, are crucial to prevent unfavorable outcomes in patients with established PAD as it is possible for an individual to engage in a significant amount of moderate to vigorous physical activity and have high levels of sedentary time within the same day.

The RESPONSE-2-PAD program will be evaluated in a pilot study involving 50 patients living with peripheral arterial disease. They will be recruited through the vascular services at University Hospital Galway. Those potentially interested will be provided with an information sheet. Participants will take part in an initial assessment which will measure their sitting time, physical activity participation and their six-minute walking distance. They will then take part in a 12-week individually tailored, coaching-based intervention. This intervention will be delivered remotely. The intervention involves the use of an activity tracker(sedentary reminder) and an online structured education program coupled with coaching calls (10-15minutes) that review sitting time and activity goals weekly. At 12-weeks all participants will be invited to a follow up assessment where sitting time, activity participation and six-minute walking distance will be remeasured. Patients will also be invited to take part in a semi-structured interview to explore their views and opinions of the program and its acceptability. At six months all patients will be invited for a final follow-up measurement of their sitting time, physical activity participation and six-minute walking distance in order to evaluate longer term changes.

Being tested
RESPONSE-2-PAD
Keywords
peripheral arterial disease, sedentary lifestyle, Sitting time
Medical subject headings
Peripheral Arterial Disease, Sedentary Behavior, Peripheral Arterial Occlusive Disease 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RESPONSE-2-PADBehavioural

    The RESPONSE-2-PAD program will undergo evaluation through a pilot study includes 50 patients living with peripheral arterial disease. Participants will take part in an initial assessment which will measure their sedentary time/physical activity using activPAL and their six-minute walking distance. They will then take part in a 12-week tailored, coaching-based intervention delivered remotely. The intervention involves the use of an activity tracker (sedentary reminder) and an online structured education program coupled with coaching calls that review sedentary time and activity goals weekly. At 12-weeks all participants will be invited to a follow up assessment. Participants will also be invited to take part in a semi-structured interview to explore their views and opinions of the program and its acceptability. At six months all patients will be invited for a final follow-up measurements.

Study groups in NCT05961943
Study groupRoleWhat they receive
RESPONSE-2-PADExperimentalAll participants will use the activPAL accelerometer to quantify sedentary time/physical activity. The 6-minute-walk test will be assessed. Participants will receive the 12 week tailored intervention (RESPONSE-2-PAD link, coaching calls and activity tracker). Participants will be followed up at 12-weeks and again at six months.
Receives: Behavioral: RESPONSE-2-PAD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluating the impact of the Multicomponent Intervention (RESPONSE-2-PAD) on sedentary time in individuals with PAD.

    This study will assess sedentary time in hours at baseline. After a 12-week intervention and a 6-month follow-up, sedentary time will be reassessed using the activPAL accelerometer, as done at baseline. Data analysis will evaluate changes in sedentary time from baseline to post-intervention using statistical methods to assess the effectiveness of the multicomponent intervention.

    Measured: Participants recruited for 6 months. Sedentary time assessed at baseline, after 12-week intervention, and at 6-month follow-up. Comprehensive evaluation of sedentary behavior throughout the study.

  2. Assessing the participant involvement in RESPONSE-2-PAD Intervention to Reduce Sedentary Time.

    This study aims to evaluate the level of participant engagement in the RESPONSE-2-PAD intervention, which is designed to reduce sedentary time. Through a semi structured interview. We will assess participants' involvement, motivation, and adherence to the intervention.

    Measured: At the end of the 6-month follow-up period, participants will be interviewed to gather qualitative feedback.

Secondary outcomes (2)
  1. Assessing the change in physical activity level in individuals with PAD using a Multicomponent Intervention (RESPONSE-2-PAD).

    Moderate to vigorous physical activity (MVPA) hours will be assessed at baseline. After the intervention period (12 weeks) and 6 months follow up will be reassessed using the activPAL accelerometer as before the intervention. Then data will be analyzed to assess the changes in MVPA from baseline to post-intervention. Statistical methods will be employed to compare pre- and post-intervention MVPA and evaluate the effectiveness of the multicomponent intervention.

    Measured: Participants recruited for 6 months. MVPA assessed at baseline, after 12-week intervention, and at 6-month follow-up.

  2. Assessing the Efficacy of the RESPONSE-2-PAD Program Using the 6-Minute Walk Test (6MWT) to Improve Symptom-Free Walking Distance.

    This study aims to evaluate the effectiveness of the RESPONSE-2-PAD program in improving symptom-free walking distance using the six-minute walking test (6MWT). The assessment will include measuring total meters scored, initial claudication distance, and absolute claudication distance in participants with peripheral arterial disease (PAD).

    Measured: 6-Minute Walk Test (6MWT) Assessments: Baseline: Before starting the intervention Post-Intervention: At the end of the 12-week intervention period Follow-Up: 6 months after the completion of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2023
  2. Study start29 Sep 2023
  3. Primary completionJan 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Study recruitment will be conducted at the vascular outpatient clinic at Galway University Hospitals (GUH), Ireland. Those who consent will then be invited to attend a baseline assessment. All participants will be provided with an activPAL accelerometer device to use for seven consecutive days. Patients will also complete the six-minute walk test (6-MWT) using timed walk application. Participants will then commence the 12-week tailored intervention to empower participants to reduce/interrupt their sedentary time. Participants will have access to an online education session via the RESPONSE-2-PAD link. The researcher will support and motivate participants to reduce/interrupt their sitting time by contacting them through phone or video coaching calls once a week, on average lasting 10-15 minutes. an activity tracker will be used as a sedentary reminder. Participants will be followed up at 12-weeks and again at six months.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05961943
Sponsor's protocol ID
C.A.2970
Status last verified
Apr 2024
First submitted
10 Jul 2023
Last updated
9 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Only the relevant data will be collected and stored in Galway university hospital. The data relevant to this study will only be stored for 5 more years after the thesis is written and the research has been published in peer-reviewed journals.

Publications

  • Bailey DP, Edwardson CL, Pappas Y, Dong F, Hewson DJ, Biddle SJH, Brierley ML, Chater AM. A randomised-controlled feasibility study of the REgulate your SItting Time (RESIT) intervention for reducing sitting time in individuals with type 2 diabetes: study protocol. Pilot Feasibility Stud. 2021 Mar 19;7(1):76. doi: 10.1186/s40814-021-00816-0.

    PubMed 33741077
  • Chastin SFM, Dontje ML, Skelton DA, Cukic I, Shaw RJ, Gill JMR, Greig CA, Gale CR, Deary IJ, Der G, Dall PM; Seniors USP team. Systematic comparative validation of self-report measures of sedentary time against an objective measure of postural sitting (activPAL). Int J Behav Nutr Phys Act. 2018 Feb 26;15(1):21. doi: 10.1186/s12966-018-0652-x.

    PubMed 29482617
  • Martin A, Fitzsimons C, Jepson R, Saunders DH, van der Ploeg HP, Teixeira PJ, Gray CM, Mutrie N; EuroFIT consortium. Interventions with potential to reduce sedentary time in adults: systematic review and meta-analysis. Br J Sports Med. 2015 Aug;49(16):1056-63. doi: 10.1136/bjsports-2014-094524. Epub 2015 Apr 23.

    PubMed 25907181
  • Said M, Tawfick W, Edwardson CL, Carvalho M, Sultan S, Alawy M, Filandrianou E, Nolan M, Jones J. A Sedentary Behaviour Reduction Programme in Patients With Peripheral Arterial Disease: A Mixed-Method Feasibility Study. Int J Vasc Med. 2026 Apr 14;2026:1159242. doi: 10.1155/ijvm/1159242. eCollection 2026.

    PubMed 41994540

Questions about this trial

What is this clinical trial studying?

A study testing RESPONSE-2-PAD in people with Peripheral Arterial Disease and Sedentary Behavior, run by National Institute for Prevention and Cardiovascular Health, Ireland at 1 site in Ireland.

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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Apr 2024. 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 Ireland. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marwa Said (00353877374710, m.said2@nuigalway.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluating the impact of the Multicomponent Intervention (RESPONSE-2-PAD) on sedentary time in individuals with PAD. (time frame: Participants recruited for 6 months. Sedentary time assessed at baseline, after 12-week intervention, and at 6-month follow-up. Comprehensive evaluation of sedentary behavior throughout the study.). 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 NCT05961943, which also lists 4 linked publications.

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 Apr 2024.

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