Peripheral Arterial DiseaseNCT07250776
Effects of Body Awareness Therapy on Functional Capacity, With Peripheral Artery Disease
A study testing Body Awareness Therapy and Conventional Physiotherapy in people with Peripheral Arterial Disease, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
Patients will be divided into two groups. One group will receive only a conventional physiotherapy program. The conventional physiotherapy program included breathing and aerobic exercises, energy conservation techniques, and activities of daily living. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Body Awareness Therapy and Conventional Physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2025to 17 Nov 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Peripheral Artery Disease (PAD) (confirmed by Doppler ultrasonography or Ankle-Brachial Index (ABI) ≤ 0.90).
- Being between 40 and 75 years of age.
- Having Stage II-III PAD.
- Being able to walk independently or with minimal support.
- Being fit for exercise with cardiac or pulmonary functions.
- Having a cognitive level sufficient to participate in body awareness training.
- Having a stable cardiovascular status (not having had an acute cardiac event, myocardial infarction, or stroke) within the last 6 months.
- Agreeing to actively participate in the study and signing the informed consent form.
Who cannot join
- Having Stage IV PAD.
- Individuals unable to carry out daily activities due to severe rest pain.
- Serious cardiovascular, pulmonary, neurological, cognitive, or musculoskeletal diseases
- Those who have had a myocardial infarction, stroke, or surgery within the last 6 months.
- Uncontrolled hypertension, heart failure, respiratory failure, or dependence on oxygen support
- Active infection or inflammatory diseases
- Uncontrolled diabetes or renal failure
- Missed 2 consecutive sessions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University, Farabi Hospital
Trabzon, Türkiye, 34033
About this study
Official title: Effects of Body Awareness Therapy on Physical Psychosocial Outcomes in Peripheral Artery Disease: A Randomized Controlled Trial
Patients will be divided into two groups. One group will receive only a conventional physiotherapy program. The conventional physiotherapy program included breathing and aerobic exercises, energy conservation techniques, and activities of daily living. The exercises were supervised once a week and unsupervised for six days. The program was administered 1 x 7 x 8 hours/day/week.
The experimental group received Body Awareness therapy in addition to the conventional physiotherapy program. The exercise content included relaxation exercises, breathing exercises, floor exercises for trunk and pelvic movements, and extremity movements. Body Awareness Therapy was also administered 1 x 7 x 8 hours/day/week.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Body Awareness Therapy, Conventional Physiotherapy
- Keywords
- Body Awareness Therapy, rehabilitation
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Awareness TherapyProcedure or surgery
The Body Awareness Therapy content included relaxation exercises, breathing exercises, floor exercises for trunk and pelvic movements, and extremity movements. Body Awareness Therapy was also administered 1 x 7 x 8 hours/day/week.
Conventional PhysiotherapyProcedure or surgery
The conventional physiotherapy program included breathing and aerobic exercises, energy conservation techniques, and activities of daily living. The exercises were supervised once a week and unsupervised for six days. The program was administered 1 x 7 x 8 hours/day/week.
| Study group | Role | What they receive |
|---|---|---|
| Body Awareness Therapy Group | Experimental | Physiotherapy and body awareness therapy were applied Receives: Procedure: Body Awareness Therapy; Procedure: Conventional Physiotherapy |
| Conventional Therapy Group | Active comparator | Physiotherapy was applied. Receives: Procedure: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute Walk Test
Measured: Baseline
6-Minute Walk Test
Measured: End of the 8th week
Muscle Strength
For Quadriceps and Hamstring muscles with hand-held dynamometer
Measured: Baseline
Muscle Strength
For Quadriceps and Hamstring muscles with hand-held dynamometer
Measured: End of the 8th week
Body Awareness Questionnaire (BAQ)
The total score on the scale is between 18 and 126. A high score indicates a high level of awareness.
Measured: Baseline
Body Awareness Questionnaire (BAQ)
The total score on the scale is between 18 and 126. A high score indicates a high level of awareness.
Measured: End of the 8th week
Visual Analog Scale
Durnig resting, at Night and After Training. A high score indicates a high level of pain intensity.
Measured: Baseline
Visual Analog Scale
Durnig resting, at Night and After Training. A high score indicates a high level of pain intensity.
Measured: End of the 8th week
Claudication Onset Distance
Measured: Baseline
Claudication Onset Distance
Measured: End of the 8th week
Absolute Claudication Distance
Measured: Baseline
Absolute Claudication Distance
Measured: End of the 8th week
Pain Catastrophizing Scale
The total score ranges from 0 to 52. Higher scores indicate greater levels of pain catastrophizing.
Measured: Baseline
Pain Catastrophizing Scale
The total score ranges from 0 to 52. Higher scores indicate greater levels of pain catastrophizing.
Measured: End of the 8th week
Pittsburgh Sleep Quality Index
The total score ranges from 0 to 21. Higher scores reflect poorer sleep quality.
Measured: Baseline
Pittsburgh Sleep Quality Index
The total score ranges from 0 to 21. Higher scores reflect poorer sleep quality.
Measured: End of the 8th week
Multidimensional Scale of Perceived Social Support
The total score ranges from 12 to 84. Higher scores indicate greater perceived social support.
Measured: Baseline
Multidimensional Scale of Perceived Social Support
The total score ranges from 12 to 84. Higher scores indicate greater perceived social support.
Measured: End of the 8th week
Perceived Stress Scale (PSS-10)
The total score ranges from 0 to 40. Higher scores indicate higher perceived stress.
Measured: Baseline
Perceived Stress Scale (PSS-10)
The total score ranges from 0 to 40. Higher scores indicate higher perceived stress.
Measured: End of the 8th week
Hospital Anxiety and Depression Scale
Each subscale (Anxiety and Depression) ranges from 0 to 21. Higher scores indicate greater anxiety or depressive symptoms.
Measured: Baseline
Hospital Anxiety and Depression Scale
Each subscale (Anxiety and Depression) ranges from 0 to 21. Higher scores indicate greater anxiety or depressive symptoms.
Measured: End of the 8th week
Tampa Scale of Kinesiophobia
The total score ranges from 17 to 68. Higher scores indicate greater fear of movement.
Measured: Baseline
Tampa Scale of Kinesiophobia
The total score ranges from 17 to 68. Higher scores indicate greater fear of movement.
Measured: End of the 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start30 Jun 2025
- Primary completion17 Nov 2025
- Study completion17 Nov 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 Peripheral Arterial DiseaseStudies 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Şenocak, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250776
- Sponsor's protocol ID
- 2025/68
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karaca S, Senocak E, Yuruk MA. Body Awareness Therapy in Peripheral Arterial Disease: A Randomized Controlled Trial. Pain Manag Nurs. 2026 May 17:S1524-9042(26)00162-1. doi: 10.1016/j.pmn.2026.04.023. Online ahead of print.
PubMed 42144309
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Body Awareness Therapy on Physical Psychosocial Outcomes in Peripheral Artery Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07250776
- Acronym / sponsor ID
- 2025/68
- Conditions
- Peripheral Arterial Disease
- Keywords
- Body Awareness Therapy, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 17 Nov 2025 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 26 Nov 2025 (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.
Patients will be divided into two groups. One group will receive only a conventional physiotherapy program. The conventional physiotherapy program included breathing and aerobic exercises, energy conservation techniques, and activities of daily living. The exercises were supervised once a week and unsupervised for six days. The program was administered 1 x 7 x 8 hours/day/week.
The experimental group received Body Awareness therapy in addition to the conventional physiotherapy program. The exercise content included relaxation exercises, breathing exercises, floor exercises for trunk and pelvic movements, and extremity movements. Body Awareness Therapy was also administered 1 x 7 x 8 hours/day/week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body Awareness Therapy Group | Experimental | Procedure: Body Awareness Therapy, Procedure: Conventional PhysiotherapyPhysiotherapy and body awareness therapy were applied |
| Conventional Therapy Group | Active comparator | Procedure: Conventional PhysiotherapyPhysiotherapy was applied. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of Peripheral Artery Disease (PAD) (confirmed by Doppler ultrasonography or Ankle-Brachial Index (ABI) ≤ 0.90).
- Being between 40 and 75 years of age.
- Having Stage II-III PAD.
- Being able to walk independently or with minimal support.
- Being fit for exercise with cardiac or pulmonary functions.
Key exclusion criteria (8 listed)
- Having Stage IV PAD.
- Individuals unable to carry out daily activities due to severe rest pain.
- Serious cardiovascular, pulmonary, neurological, cognitive, or musculoskeletal diseases
- Those who have had a myocardial infarction, stroke, or surgery within the last 6 months.
- Uncontrolled hypertension, heart failure, respiratory failure, or dependence on oxygen support
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 |
|---|---|---|
| Body Awareness TherapyThe Body Awareness Therapy content included relaxation exercises, breathing exercises, floor exercises for trunk and pelvic movements, and extremity movements. Body Awareness Therapy was also administered 1 x 7 x 8 hours/day/week. | Procedure or surgery | Body Awareness Therapy Group |
| Conventional PhysiotherapyThe conventional physiotherapy program included breathing and aerobic exercises, energy conservation techniques, and activities of daily living. The exercises were supervised once a week and unsupervised for six days. The program was administered 1 x 7 x 8 hours/day/week. | Procedure or surgery | Body Awareness Therapy Group, Conventional Therapy Group |
Primary outcome
6-Minute Walk Test
Time frame: Baseline
6-Minute Walk Test
Time frame: End of the 8th week
Muscle Strength
Time frame: Baseline
For Quadriceps and Hamstring muscles with hand-held dynamometer
Muscle Strength
Time frame: End of the 8th week
For Quadriceps and Hamstring muscles with hand-held dynamometer
Body Awareness Questionnaire (BAQ)
Time frame: Baseline
The total score on the scale is between 18 and 126. A high score indicates a high level of awareness.
Body Awareness Questionnaire (BAQ)
Time frame: End of the 8th week
The total score on the scale is between 18 and 126. A high score indicates a high level of awareness.
Visual Analog Scale
Time frame: Baseline
Durnig resting, at Night and After Training. A high score indicates a high level of pain intensity.
Visual Analog Scale
Time frame: End of the 8th week
Durnig resting, at Night and After Training. A high score indicates a high level of pain intensity.
Claudication Onset Distance
Time frame: Baseline
Claudication Onset Distance
Time frame: End of the 8th week
Absolute Claudication Distance
Time frame: Baseline
Absolute Claudication Distance
Time frame: End of the 8th week
Pain Catastrophizing Scale
Time frame: Baseline
The total score ranges from 0 to 52. Higher scores indicate greater levels of pain catastrophizing.
Pain Catastrophizing Scale
Time frame: End of the 8th week
The total score ranges from 0 to 52. Higher scores indicate greater levels of pain catastrophizing.
Pittsburgh Sleep Quality Index
Time frame: Baseline
The total score ranges from 0 to 21. Higher scores reflect poorer sleep quality.
Pittsburgh Sleep Quality Index
Time frame: End of the 8th week
The total score ranges from 0 to 21. Higher scores reflect poorer sleep quality.
Multidimensional Scale of Perceived Social Support
Time frame: Baseline
The total score ranges from 12 to 84. Higher scores indicate greater perceived social support.
Multidimensional Scale of Perceived Social Support
Time frame: End of the 8th week
The total score ranges from 12 to 84. Higher scores indicate greater perceived social support.
Perceived Stress Scale (PSS-10)
Time frame: Baseline
The total score ranges from 0 to 40. Higher scores indicate higher perceived stress.
Perceived Stress Scale (PSS-10)
Time frame: End of the 8th week
The total score ranges from 0 to 40. Higher scores indicate higher perceived stress.
Hospital Anxiety and Depression Scale
Time frame: Baseline
Each subscale (Anxiety and Depression) ranges from 0 to 21. Higher scores indicate greater anxiety or depressive symptoms.
Hospital Anxiety and Depression Scale
Time frame: End of the 8th week
Each subscale (Anxiety and Depression) ranges from 0 to 21. Higher scores indicate greater anxiety or depressive symptoms.
Tampa Scale of Kinesiophobia
Time frame: Baseline
The total score ranges from 17 to 68. Higher scores indicate greater fear of movement.
Tampa Scale of Kinesiophobia
Time frame: End of the 8th week
The total score ranges from 17 to 68. Higher scores indicate greater fear of movement.
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 26 Nov 2025.
- Derived from this study: PubMed 42144309Karaca S, Senocak E, Yuruk MA. Body Awareness Therapy in Peripheral Arterial Disease: A Randomized Controlled Trial. Pain Manag Nurs. 2026 May 17:S1524-9042(26)00162-1. doi: 10.1016/j.pmn.2026.04.023. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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 Body Awareness Therapy and Conventional Physiotherapy in people with Peripheral Arterial Disease, run by Karadeniz Technical 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 8 inclusion and 8 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 26 Nov 2025. 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?
6-Minute Walk Test (time frame: Baseline). The study lists 24 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 NCT07250776, 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 26 Nov 2025.