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

NCT07250776 | Completed

• 1 other identifier: 2025/68
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

Body Awareness Therapy; rehabilitation

Outcome Measures

Primary Outcomes (24)

• 6-Minute Walk Test

  Baseline

• 6-Minute Walk Test

  End of the 8th week

• Muscle Strength

  For Quadriceps and Hamstring muscles with hand-held dynamometer

  Baseline

• Muscle Strength

  For Quadriceps and Hamstring muscles with hand-held dynamometer

  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.

  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.

  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.

  Baseline

• Visual Analog Scale

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

  End of the 8th week

• Claudication Onset Distance

  Baseline

• Claudication Onset Distance

  End of the 8th week

• Absolute Claudication Distance

  Baseline

• Absolute Claudication Distance

  End of the 8th week

• Pain Catastrophizing Scale

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

  Baseline

• Pain Catastrophizing Scale

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

  End of the 8th week

• Pittsburgh Sleep Quality Index

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

  Baseline

• Pittsburgh Sleep Quality Index

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

  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.

  Baseline

• Multidimensional Scale of Perceived Social Support

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

  End of the 8th week

• Perceived Stress Scale (PSS-10)

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

  Baseline

• Perceived Stress Scale (PSS-10)

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

  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.

  Baseline

• Hospital Anxiety and Depression Scale

  Each subscale (Anxiety and Depression) ranges from 0 to 21. Higher scores indicate greater anxiety or depressive symptoms.

  End of the 8th week

• Tampa Scale of Kinesiophobia

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

  Baseline

• Tampa Scale of Kinesiophobia

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

  End of the 8th week

Study Arms (2)

Body Awareness Therapy Group

EXPERIMENTAL

Physiotherapy and body awareness therapy were applied

Procedure: Body Awareness Therapy; Procedure: Conventional Physiotherapy

Conventional Therapy Group

ACTIVE COMPARATOR

Physiotherapy was applied.

Procedure: Conventional Physiotherapy

Interventions

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.

Body Awareness Therapy Group

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.

Body Awareness Therapy Group; Conventional Therapy Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University, Farabi Hospital

Trabzon, Türkiye, 34033, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: June 30, 2025
• Primary Completion: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)