Peripheral Arterial DiseaseNCT07877129
Exploring the Exercise Fear Experiences of Patients With Peripheral Arterial Disease: A Qualitative Study
An observational study of Peripheral Arterial Disease, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
This study explored the exercise fear experience of patients with lower extremity arteriosclerosis obliterans. We conducted qualitative interviews and identified four core themes contributing to patients' fear of physical activity, including physical discomfort, negative psychological feelings, biased cognition, and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- a descriptive qualitative design
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 30 Apr 2026
- How long will I take part?
- 1 Day
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Peripheral arterial disease (PAD), wihch often presents clinically as lower extremity arteriosclerosis obliterans, has become a major global public health concern. Its prevalence is estimated to exceed 236 million cases worldwide[1]. The condition is characterized by chronic lower limb ischemia and the debilitating symptom of intermittent claudication, placing a significant burden on healthcare systems and reducing patients' quality of life.
Who may be able to join
- Meets the diagnostic criteria of PAD[3], (2) Age≥18 years, (3) The score on the Kinesiophobia Rating Scale > 37 points[17],(4) Clear consciousness and able to accurately express their viewpoints.
Who cannot join
- (1)severe comorbidities that independently restrict walking ability, such as advanced osteoarthritis, uncompensated heart failure, or severe chronic obstructive pulmonary disease; (2) cognitive impairment, dementia, or severe psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
This study explored the exercise fear experience of patients with lower extremity arteriosclerosis obliterans. We conducted qualitative interviews and identified four core themes contributing to patients' fear of physical activity, including physical discomfort, negative psychological feelings, biased cognition, and inadequate social and medical support. The findings explained how exercise fear gradually develops and forms a vicious cycle of activity avoidance. Based on patients' real experience, we proposed a targeted exercise support framework. This research helps clinical staff better understand patients' inner barriers to exercise, carry out individualized psychological and rehabilitation interventions, improve patients' exercise adherence, and promote long-term disease rehabilitation.
- Conditions
- Peripheral Arterial Disease
- Being tested
- a descriptive qualitative design
- Keywords
- Peripheral arterial disease, Exercise fear, Kinesiophobia, Qualitative study, Fear- Avoidance Model, Exercise adherence
- Medical subject headings
- Peripheral Arterial Disease, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a descriptive qualitative designOther
The finalized formal interview outline included the following questions: (1) What do you think about exercise and rehabilitation in daily life? (2) Could you tell me about your experiences with physical activities or exercise since your diagnosis? (3) How has exercise fear changed your daily exercise behavior? (4) What impact do you think exercise fear has had on your life? (5) How do you cope with the experience of exercise fear?(6) In response to the current situation, what kind of support do you hope to receive during the exercise rehabilitation?
| Study group | Role | What they receive |
|---|---|---|
| PAD | Peripheral arterial disease (PAD), wihch often presents clinically as lower extremity arteriosclerosis obliterans, has become a major global public health concern. Its prevalence is estimated to exceed 236 million cases worldwide Receives: Other: a descriptive qualitative design |
What is being measured
The primary outcome is the main question the study is designed to answer.
TSK（Tampa Scale for Kinesiophobia）
TSK measure the extent of fear in PAD populations
Measured: 2026.01-2026.04
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Jan 2026
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 18 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaodan Zhu, bachelor, Principal investigator, The Fourth Affiliated Hospital of Zhejiang University School of MedicineXiaodan Zhu, bachelor, Study director, The Fourth Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877129
- Sponsor's protocol ID
- KY-2026-024
- Status last verified
- Jan 2026
- First submitted
- 9 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Deng L, Du C, Liu L, Wang Y, Gu H, Armstrong DG, Mills JL, Hochlenert D, Deng H, Ran J, Chen Y, Jiang X, Ma Y, Chen Q, Deng W; "Flow and Toe" Research Team (FORT)double dagger. Forecasting the Global Burden of Peripheral Artery Disease from 2021 to 2050: A Population-Based Study. Research (Wash D C). 2025 Jul 1;8:0702. doi: 10.34133/research.0702. eCollection 2025.
PubMed 40599301Yan C, Chen J, Xu X, Wei H, Li J. Global burden of peripheral arterial disease (1990-2021), global burden trends and the impact of blood lead on peripheral arterial disease: a multidimensional analysis based on NHANES, GBD, and Mendelian randomization. J Transl Med. 2025 Apr 23;23(1):463. doi: 10.1186/s12967-025-06408-3.
PubMed 40269919
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Exercise Fear Experiences of Patients With Peripheral Arterial Disease: A Qualitative Study
- ClinicalTrials.gov ID
- NCT07877129
- Acronym / sponsor ID
- KY-2026-024
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral arterial disease, Exercise fear, Kinesiophobia, Qualitative study, Fear- Avoidance Model, Exercise adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 16 Oct 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.
This study explored the exercise fear experience of patients with lower extremity arteriosclerosis obliterans. We conducted qualitative interviews and identified four core themes contributing to patients' fear of physical activity, including physical discomfort, negative psychological feelings, biased cognition, and inadequate social and medical support. The findings explained how exercise fear gradually develops and forms a vicious cycle of activity avoidance. Based on patients' real experience, we proposed a targeted exercise support framework. This research helps clinical staff better understand patients' inner barriers to exercise, carry out individualized psychological and rehabilitation interventions, improve patients' exercise adherence, and promote long-term disease rehabilitation.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAD | – | Other: a descriptive qualitative designPeripheral arterial disease (PAD), wihch often presents clinically as lower extremity arteriosclerosis obliterans, has become a major global public health concern. Its prevalence is estimated to exceed 236 million cases worldwide |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Peripheral arterial disease (PAD), wihch often presents clinically as lower extremity arteriosclerosis obliterans, has become a major global public health concern. Its prevalence is estimated to exceed 236 million cases worldwide[1]. The condition is characterized by chronic lower limb ischemia and the debilitating symptom of intermittent claudication, placing a significant burden on healthcare systems and reducing patients' quality of life.
Key inclusion criteria (1 listed)
- Meets the diagnostic criteria of PAD[3], (2) Age≥18 years, (3) The score on the Kinesiophobia Rating Scale > 37 points[17],(4) Clear consciousness and able to accurately express their viewpoints.
Key exclusion criteria (1 listed)
- (1)severe comorbidities that independently restrict walking ability, such as advanced osteoarthritis, uncompensated heart failure, or severe chronic obstructive pulmonary disease; (2) cognitive impairment, dementia, or severe psychiatric disorders.
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 |
|---|---|---|
| a descriptive qualitative designThe finalized formal interview outline included the following questions: (1) What do you think about exercise and rehabilitation in daily life? (2) Could you tell me about your experiences with physical activities or exercise since your diagnosis? (3) How has exercise fear changed your daily exercise behavior? (4) What impact do you think exercise fear has had on your life? (5) How do you cope with the experience of exercise fear?(6) In response to the current situation, what kind of support do you hope to receive during the exercise rehabilitation? | Other | PAD |
Primary outcome
TSK（Tampa Scale for Kinesiophobia）
Time frame: 2026.01-2026.04
TSK measure the extent of fear in PAD populations
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 16 Oct 2026.
- Results publication: PubMed 40599301Deng L, Du C, Liu L, Wang Y, Gu H, Armstrong DG, Mills JL, Hochlenert D, Deng H, Ran J, Chen Y, Jiang X, Ma Y, Chen Q, Deng W; "Flow and Toe" Research Team (FORT)double dagger. Forecasting the Global Burden of Peripheral Artery Disease from 2021 to 2050: A Population-Based Study. Research (Wash D C). 2025 Jul 1;8:0702. doi: 10.34133/research.0702. eCollection 2025.
- Results publication: PubMed 40269919Yan C, Chen J, Xu X, Wei H, Li J. Global burden of peripheral arterial disease (1990-2021), global burden trends and the impact of blood lead on peripheral arterial disease: a multidimensional analysis based on NHANES, GBD, and Mendelian randomization. J Transl Med. 2025 Apr 23;23(1):463. doi: 10.1186/s12967-025-06408-3.
- Individual participant dataSharing planned: Yes
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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.
Xiaodan Zhu, bachelor principal investigator
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Xiaodan Zhu, bachelor study director
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
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 Peripheral Arterial Disease, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
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 1 inclusion and 1 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 16 Oct 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 China. 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?
TSK（Tampa Scale for Kinesiophobia） (time frame: 2026.01-2026.04). 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 NCT07877129, which also lists 2 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 16 Oct 2026.