BEHAVIOR CHANGE-BASED PHYSICAL ACTIVITY INTERVENTION IN PAD PATIENTS AFTER ENDOVASCULAR REVASCULARIZATIONNCT07328646
BEHAVIOR CHANGE INTERVENTION AFTER ENDOVASCULAR REVASCULARIZATION IN PAD
A study testing Behavior Change-Based Physical Activity Program, Supervised Exercise Program and Combined Behavior Change and Exercise Program in people with BEHAVIOR CHANGE-BASED PHYSICAL ACTIVITY INTERVENTION IN PAD PATIENTS AFTER ENDOVASCULAR REVASCULARIZATION, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
The study titled "Investigation of the Effect of a Behavior Change-Based Physical Activity Program in Patients with Peripheral Artery Disease Who Have Undergone Endovascular Revascularization" will be conducted by Specialist Physiotherapist Ayşe ADIGÜZEL BAYAR. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- BEHAVIOR CHANGE-BASED PHYSICAL ACTIVITY INTERVENTION IN PAD PATIENTS AFTER ENDOVASCULAR REVASCULARIZATION
- What is being tested?
- Behavior Change-Based Physical Activity Program, Supervised Exercise Program and Combined Behavior Change and Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jun 2024to 15 Dec 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants
- Aged between 50 and 80 years
- Able to read, understand, and write Turkish
- Scheduled to undergo endovascular revascularization for peripheral artery disease
Who cannot join
- Positive exercise stress test result
- Presence of cognitive or intellectual impairment
- Presence of musculoskeletal or neurological conditions that may interfere with physical activity performance or outcome assessment
- Presence of unstable chronic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Özel Medinova Hastanesi
Efeler, Aydın, 09100
About this study
Official title: EFFECTIVENESS OF A BEHAVIOR CHANGE INTERVENTION AIMED AT INCREASING PHYSICAL ACTIVITY IN PATIENTS WITH PERIPHERAL ARTERY DISEASE UNDERGOING ENDOVASCULAR REVASCULARIZATION
The study titled "Investigation of the Effect of a Behavior Change-Based Physical Activity Program in Patients with Peripheral Artery Disease Who Have Undergone Endovascular Revascularization" will be conducted by Specialist Physiotherapist Ayşe ADIGÜZEL BAYAR. The study is designed to investigate the effects of a structured physical activity program planned using behavior change techniques after endovascular revascularization on walking capacity, physical function, physical activity level and quality of life in patients with peripheral artery disease.
- Being tested
- Behavior Change-Based Physical Activity Program, Supervised Exercise Program, Combined Behavior Change and Exercise Program
- Keywords
- Peripheral Artery Disease, Endovascular Revascularization, Physical Activity, Exercise Therapy, Behavior Change, Walking Capacity, Physical Function, Sedentary Behavior, Quality of Life
- Medical subject headings
- Peripheral Arterial Disease, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior Change-Based Physical Activity ProgramBehavioural
The program will include behavior change techniques such as goal setting, self-monitoring, action planning, motivational support, and education to promote physical activity and reduce sedentary time.
Supervised Exercise ProgramOther
The supervised exercise program will consist of structured exercise sessions aimed at improving walking capacity and physical function.
Combined Behavior Change and Exercise ProgramOther
This intervention integrates behavior change techniques with supervised exercise to enhance physical activity adherence, walking capacity, physical function, and quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Behavior Change Intervention Group | Experimental | Participants in this arm will receive a structured behavior change-based physical activity intervention following endovascular revascularization. Receives: Behavioral: Behavior Change-Based Physical Activity Program |
| Supervised Exercise Group | Active comparator | Participants in this arm will receive a supervised exercise program following endovascular revascularization, without a structured behavior change component. Receives: Other: Combined Behavior Change and Exercise Program |
| Combined Intervention Group | Experimental | Participants in this arm will receive a combined intervention including both a behavior change-based. Receives: Other: Supervised Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported physical activity level (IPAQ total score)
Self-reported physical activity level will be assessed using the International Physical Activity Questionnaire (IPAQ). The primary outcome is the change in total physical activity level, expressed as MET-minutes per week, from baseline.
Measured: Baseline, 6 weeks, 12 weeks
Secondary outcomes (4)
Change in walking capacity (6-Minute Walk Test distance)
Walking capacity will be assessed using the 6-Minute Walk Test. The primary endpoint is the change in 6MWT distance (meters) from baseline.
Measured: Baseline, 6 weeks, 12 weeks
Change in physical function (SPPB total score)
Physical function will be evaluated using the Short Physical Performance Battery (SPPB). The outcome is the change in SPPB total score from baseline.
Measured: Baseline, 6 weeks, 12 weeks
Change in walking impairment (WIQ total score)
Walking impairment will be evaluated using the Walking Impairment Questionnaire (WIQ). The outcome is change in WIQ total score from baseline.
Measured: Baseline, 6 weeks, 12 weeks
Change in quality of life (SF-12 PCS and MCS)
Quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12). Outcomes include changes in Physical Component Summary (PCS) and Mental Component Summary (MCS) scores.
Measured: Baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start29 Jun 2024
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
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 BEHAVIOR CHANGE-BASED PHYSICAL ACTIVITY INTERVENTION IN PAD PATIENTS AFTER ENDOVASCULAR REVASCULARIZATIONStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Adıgüzel Bayar, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328646
- Sponsor's protocol ID
- Phd Thesis
- Status last verified
- Sep 2026
- First submitted
- 27 Dec 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be shared due to ethical and privacy considerations, as well as the absence of explicit participant consent for data sharing. The study involves a relatively small sample size, which may increase the risk of participant re-identification. Data will be reported only in aggregate form in scientific publications.
Publications
Gardner AW, Montgomery PS, Wang M, Shen B. Minimal clinically important differences in daily physical activity outcomes following supervised and home-based exercise in peripheral artery disease. Vasc Med. 2022 Apr;27(2):142-149. doi: 10.1177/1358863X211072913. Epub 2022 Feb 15.
PubMed 35164605
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF A BEHAVIOR CHANGE INTERVENTION AIMED AT INCREASING PHYSICAL ACTIVITY IN PATIENTS WITH PERIPHERAL ARTERY DISEASE UNDERGOING ENDOVASCULAR REVASCULARIZATION
- ClinicalTrials.gov ID
- NCT07328646
- Acronym / sponsor ID
- Phd Thesis
- Keywords
- Peripheral Artery Disease, Endovascular Revascularization, Physical Activity, Exercise Therapy, Behavior Change, Walking Capacity, Physical Function, Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 29 Jun 2024 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 9 Jan 2026 (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 titled "Investigation of the Effect of a Behavior Change-Based Physical Activity Program in Patients with Peripheral Artery Disease Who Have Undergone Endovascular Revascularization" will be conducted by Specialist Physiotherapist Ayşe ADIGÜZEL BAYAR. The study is designed to investigate the effects of a structured physical activity program planned using behavior change techniques after endovascular revascularization on walking capacity, physical function, physical activity level and quality of life in patients with peripheral artery disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavior Change Intervention Group | Experimental | Behavioral: Behavior Change-Based Physical Activity ProgramParticipants in this arm will receive a structured behavior change-based physical activity intervention following endovascular revascularization. |
| Supervised Exercise Group | Active comparator | Other: Combined Behavior Change and Exercise ProgramParticipants in this arm will receive a supervised exercise program following endovascular revascularization, without a structured behavior change component. |
| Combined Intervention Group | Experimental | Other: Supervised Exercise ProgramParticipants in this arm will receive a combined intervention including both a behavior change-based. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female participants
- Aged between 50 and 80 years
- Able to read, understand, and write Turkish
- Scheduled to undergo endovascular revascularization for peripheral artery disease
Key exclusion criteria (4 listed)
- Positive exercise stress test result
- Presence of cognitive or intellectual impairment
- Presence of musculoskeletal or neurological conditions that may interfere with physical activity performance or outcome assessment
- Presence of unstable chronic 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 |
|---|---|---|
| Behavior Change-Based Physical Activity ProgramThe program will include behavior change techniques such as goal setting, self-monitoring, action planning, motivational support, and education to promote physical activity and reduce sedentary time. | Behavioural | Behavior Change Intervention Group |
| Supervised Exercise ProgramThe supervised exercise program will consist of structured exercise sessions aimed at improving walking capacity and physical function. | Other | Combined Intervention Group |
| Combined Behavior Change and Exercise ProgramThis intervention integrates behavior change techniques with supervised exercise to enhance physical activity adherence, walking capacity, physical function, and quality of life. | Other | Supervised Exercise Group |
Primary outcome
Change in self-reported physical activity level (IPAQ total score)
Time frame: Baseline, 6 weeks, 12 weeks
Self-reported physical activity level will be assessed using the International Physical Activity Questionnaire (IPAQ). The primary outcome is the change in total physical activity level, expressed as MET-minutes per week, from baseline.
4 secondary outcomes
Change in walking capacity (6-Minute Walk Test distance)
Time frame: Baseline, 6 weeks, 12 weeks
Change in physical function (SPPB total score)
Time frame: Baseline, 6 weeks, 12 weeks
Change in walking impairment (WIQ total score)
Time frame: Baseline, 6 weeks, 12 weeks
Change in quality of life (SF-12 PCS and MCS)
Time frame: Baseline, 6 weeks, 12 weeks
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 28 Sep 2026.
- Background: PubMed 35164605Gardner AW, Montgomery PS, Wang M, Shen B. Minimal clinically important differences in daily physical activity outcomes following supervised and home-based exercise in peripheral artery disease. Vasc Med. 2022 Apr;27(2):142-149. doi: 10.1177/1358863X211072913. Epub 2022 Feb 15.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be shared due to ethical and privacy considerations, as well as the absence of explicit participant consent for data sharing. The study involves a relatively small sample size, which may increase the risk of participant re-identification. Data will be reported only in aggregate form in scientific publications.
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 Behavior Change-Based Physical Activity Program, Supervised Exercise Program and Combined Behavior Change and Exercise Program in people with BEHAVIOR CHANGE-BASED PHYSICAL ACTIVITY INTERVENTION IN PAD PATIENTS AFTER ENDOVASCULAR REVASCULARIZATION, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 28 Sep 2026. 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 Turkey (Türkiye). 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?
Change in self-reported physical activity level (IPAQ total score) (time frame: Baseline, 6 weeks, 12 weeks). 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 NCT07328646, 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 28 Sep 2026.