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

November 25, 2025 updated by: Emre Şenocak, Karadeniz Technical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Türkiye
      • Trabzon, Türkiye, Turkey (Türkiye), 34033
        • Karadeniz Technical University, Farabi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Body Awareness Therapy Group
Physiotherapy and body awareness therapy were applied
Procedure: Body Awareness Therapy
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.
Procedure: Conventional 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.
Active Comparator: Conventional Therapy Group
Physiotherapy was applied.
Procedure: Conventional 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-Minute Walk Test
Time Frame: Baseline
Baseline
6-Minute Walk Test
Time Frame: End of the 8th week
End of the 8th week
Muscle Strength
Time Frame: Baseline
For Quadriceps and Hamstring muscles with hand-held dynamometer
Baseline
Muscle Strength
Time Frame: End of the 8th week
For Quadriceps and Hamstring muscles with hand-held dynamometer
End of the 8th week
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.
Baseline
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.
End of the 8th week
Visual Analog Scale
Time Frame: Baseline
Durnig resting, at Night and After Training. A high score indicates a high level of pain intensity.
Baseline
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.
End of the 8th week
Claudication Onset Distance
Time Frame: Baseline
Baseline
Claudication Onset Distance
Time Frame: End of the 8th week
End of the 8th week
Absolute Claudication Distance
Time Frame: Baseline
Baseline
Absolute Claudication Distance
Time Frame: End of the 8th week
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.
Baseline
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.
End of the 8th week
Pittsburgh Sleep Quality Index
Time Frame: Baseline
The total score ranges from 0 to 21. Higher scores reflect poorer sleep quality.
Baseline
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.
End of the 8th week
Multidimensional Scale of Perceived Social Support
Time Frame: Baseline
The total score ranges from 12 to 84. Higher scores indicate greater perceived social support.
Baseline
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.
End of the 8th week
Perceived Stress Scale (PSS-10)
Time Frame: Baseline
The total score ranges from 0 to 40. Higher scores indicate higher perceived stress.
Baseline
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.
End of the 8th week
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.
Baseline
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.
End of the 8th week
Tampa Scale of Kinesiophobia
Time Frame: Baseline
The total score ranges from 17 to 68. Higher scores indicate greater fear of movement.
Baseline
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.
End of the 8th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karadeniz Technical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2025

Primary Completion (Actual)

November 17, 2025

Study Completion (Actual)

November 17, 2025

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/68

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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