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Effects of Body Awareness Therapy on Functional Capacity, With Peripheral Artery Disease

Effects of Body Awareness Therapy on Physical Psychosocial Outcomes in Peripheral Artery Disease: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07250776
Enrollment
51
Registered
2025-11-26
Start date
2025-06-30
Completion date
2025-11-17
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Keywords

Body Awareness Therapy, rehabilitation

Brief 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. 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.

Interventions

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.

PROCEDUREConventional Physiotherapy

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.

Sponsors

Karadeniz Technical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
6-Minute Walk TestBaseline
Muscle StrengthBaselineFor Quadriceps and Hamstring muscles with hand-held dynamometer
Body Awareness Questionnaire (BAQ)BaselineThe total score on the scale is between 18 and 126. A high score indicates a high level of awareness.
Perceived Stress Scale (PSS-10)BaselineThe total score ranges from 0 to 40. Higher scores indicate higher perceived stress.
Hospital Anxiety and Depression ScaleBaselineEach subscale (Anxiety and Depression) ranges from 0 to 21. Higher scores indicate greater anxiety or depressive symptoms.
Visual Analog ScaleBaselineDurnig resting, at Night and After Training. A high score indicates a high level of pain intensity.
Claudication Onset DistanceBaseline
Absolute Claudication DistanceBaseline
Pain Catastrophizing ScaleBaselineThe total score ranges from 0 to 52. Higher scores indicate greater levels of pain catastrophizing.
Pittsburgh Sleep Quality IndexBaselineThe total score ranges from 0 to 21. Higher scores reflect poorer sleep quality.
Multidimensional Scale of Perceived Social SupportBaselineThe total score ranges from 12 to 84. Higher scores indicate greater perceived social support.
Tampa Scale of KinesiophobiaBaselineThe total score ranges from 17 to 68. Higher scores indicate greater fear of movement.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026