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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06426914
Other study ID # Sarosh Gohar
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 15, 2024
Est. completion date August 2024

Study information

Verified date May 2024
Source Riphah International University
Contact Mehwish Waseem, MSPT-CPPT
Phone 0331-5309015
Email mehwish.waseem@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine Effect of Clinical Pilates (CP) exercises on kinesiophobia and post-operative cardiopulmonary parameters in CABG patients. Kinesiophobia may lead to patients' psychological fear of rehabilitation exercise, thereby refusing rehabilitation exercise, affecting the rehabilitation process of patients, resulting in disuse syndrome, depression, disability and other adverse consequences. Thus, this study is to be conducted to find out the effects Pilates exercises with cardiac rehabilitation for management of Kinesiophobia in post CABG patients.


Description:

Clinical Pilates are also evident to be safe and effective in post-surgical patients with different surgical interventions. A study was conducted in 2021 to evaluate the effects of the Pilates method on pulmonary function and range of motion after coronary artery bypass grafting and concluded that the Pilates method is a safe, viable, and playful option for the patient profile after CABG but they did not evaluate kinesiophobia of patients


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria: Hemodynamically stable patient Who underwent elective CABG. Patients diagnosed with Kinesiophobia via Tampa scale for Kinesiophobia Heart (TSK-SV Heart) Exclusion Criteria: Neuromuscular conditions which lead to kinesiophobia Diseases that seriously affected the functional capacity or mobility such as liver cirrhosis, chronic renal failure and disabled patients. Prolong intubation Vital instability Patients needing maximum assistance Decline consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Clinical Pilates
Warmup: 5-10 minutes Pilates Clinical (Introductory program) The Hundred modified The Roll-up modified The roll-over modified Spine twist modified Single-leg circle modified Rolling like a ball Shoulder Bridge modified For every Step emphasizing: FOCUS: On muscle involved REPETITIONS: 3-5 VISUALIZATION: Imagination process (Different for each step) Cool down: 5 minutes Total Time: 30 minutes
Cardiac Rehabilitation
Chest Physical therapy (Chest percussions and active huffs as per need) Breathing strategies (Diaphragmatic and purse lip 1-3 sets * 5 Reps/Day) Functional mobility (walk /cycling as per patient tolerance) Patient education and Wound care Sternal Precaution guidance

Locations

Country Name City State
Pakistan Lady Reading Hospital Peshawar KPK

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Kinesiophobia Changes from baseline to 2 weeks and 4 weeks after intervention, measured through the TSK-SV Heart specifically focuses on assessing Kinesiophobia in the context of cardiac conditions or symptoms. It include questions related to fear of engaging in physical activity due to concerns about cardiac events (such as heart palpitations, chest pain, or shortness of breath) during exercise or daily activities. The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible Kinesiophobia, and the higher scores indicate an increasing degree of Kinesiophobia. 2 weeks, 4 weeks
Primary Abnormal heart rhythms Post-operative period and discharge day observed through Electrocardiography (ECG) on cardiac monitor. 2 Weeks, 6 Weeks
Secondary Functional mobility Changes from baseline to 2 weeks and 4 weeks after intervention, measured through the 10 meter walk test. It is a performance measure test used to assess walking speed in meters per second over a short distance . It can be employed to determine functional mobility. 2 weeks, 4 weeks
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