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OpenTrials
Completed

NCT Number: NCT07250776

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

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karadeniz Technical University, Farabi Hospital

Trabzon, Türkiye, 34033, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Body Awareness Therapy

Procedure

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 physiotherapy

Procedure

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.

Primary outcomes

  1. 6-Minute Walk Test

    Time frame: Baseline

  2. 6-Minute Walk Test

    Time frame: End of the 8th week

  3. Muscle Strength

    Time frame: Baseline

    For Quadriceps and Hamstring muscles with hand-held dynamometer

  4. Muscle Strength

    Time frame: End of the 8th week

    For Quadriceps and Hamstring muscles with hand-held dynamometer

  5. 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.

  6. 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.

  7. Visual Analog Scale

    Time frame: Baseline

    Durnig resting, at Night and After Training. A high score indicates a high level of pain intensity.

  8. 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.

  9. Claudication Onset Distance

    Time frame: Baseline

  10. Claudication Onset Distance

    Time frame: End of the 8th week

  11. Absolute Claudication Distance

    Time frame: Baseline

  12. Absolute Claudication Distance

    Time frame: End of the 8th week

  13. Pain Catastrophizing Scale

    Time frame: Baseline

    The total score ranges from 0 to 52. Higher scores indicate greater levels of pain catastrophizing.

  14. 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.

  15. Pittsburgh Sleep Quality Index

    Time frame: Baseline

    The total score ranges from 0 to 21. Higher scores reflect poorer sleep quality.

  16. 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.

  17. Multidimensional Scale of Perceived Social Support

    Time frame: Baseline

    The total score ranges from 12 to 84. Higher scores indicate greater perceived social support.

  18. 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.

  19. Perceived Stress Scale (PSS-10)

    Time frame: Baseline

    The total score ranges from 0 to 40. Higher scores indicate higher perceived stress.

  20. 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.

  21. 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.

  22. 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.

  23. Tampa Scale of Kinesiophobia

    Time frame: Baseline

    The total score ranges from 17 to 68. Higher scores indicate greater fear of movement.

  24. 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.

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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