## Protocol Section
### Identification Module
**NCT ID:** NCT06426914

**Brief Title:** Clinical Pilates (CP) Exercises and Kinesiophobia in CABG

**Official Title:** Effect of Clinical Pilates (CP) Exercises on Kinesiophobia and Post-operative Cardiopulmonary Parameters in CABG Patients.

#### Organization Study ID Info
**ID:** Sarosh Gohar
#### Organization
**Class:** OTHER
**Full Name:** Riphah International University
### Status Module
#### Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-19

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Riphah International University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** To determine Effect of Clinical Pilates (CP) exercises on kinesiophobia and post-operative cardiopulmonary parameters in CABG patients. Kinesiophobia may lead to patients\&#39; 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.

**Detailed 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

### Conditions Module

**Conditions:**

- Post-cardiac Surgery

**Keywords:**

- CABG

- Clinical Pilates

- Kinesiophobia

- Post-operative cardiopulmonary parameters

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 36

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Pilates Clinical (Introductory program)

**Intervention Names:**

- Other: Clinical Pilates

**Label:** Interventional

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Cardiac Rehabilitation

**Intervention Names:**

- Other: Cardiac Rehabilitation

**Label:** Control

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Interventional

**Description:** 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

**Name:** Clinical Pilates

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Control

**Description:** 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

**Name:** Cardiac Rehabilitation

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Kinesiophobia

**Time Frame:** 2 weeks, 4 weeks

**Description:** Post-operative period and discharge day observed through Electrocardiography (ECG) on cardiac monitor.

**Measure:** Abnormal heart rhythms

**Time Frame:** 2 Weeks, 6 Weeks

#### Secondary Outcomes

**Description:** 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.

**Measure:** Functional mobility

**Time Frame:** 2 weeks, 4 weeks

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 60 Years

**Minimum Age:** 30 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mehwish.waseem@riphah.edu.pk

**Name:** Mehwish Waseem, MSPT-CPPT

**Phone:** 0331-5309015

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Peshawar

**Contacts:**

***Contact 1:***

- **Email:** mehwish.waseem@riphah.edu.pk

- **Name:** Mehwish Waseem, MSPT-CPPT

- **Phone:** 0331-5309015

- **Role:** CONTACT

***Contact 2:***

- **Email:** saroshkhan424@gmail.com

- **Name:** Sarosh Gohar, MSPT-CPPT*

- **Phone:** 0303-5887220

- **Role:** CONTACT

**Country:** Pakistan

**Facility:** Lady Reading Hospital

**State:** KPK

**Status:** RECRUITING

**Zip:** 25000

#### Overall Officials

**Official 1:**

**Affiliation:** Riphah International University

**Name:** Mehwish Waseem, MSPT-CPPT

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010698

- Term: Phobic Disorders

- ID: D000001008

- Term: Anxiety Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M2922

- Name: Kinesiophobia

- Relevance: HIGH

- As Found: Kinesiophobia

- ID: M13603

- Name: Phobic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000092442

- Term: Kinesiophobia

### Misc Info Module

- Version Holder: 2024-05-31
