NCT06426914

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\' 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

May 19, 2024

Last Update Submit

March 4, 2026

Conditions

Keywords

CABGClinical PilatesKinesiophobiaPost-operative cardiopulmonary parameters

Outcome Measures

Primary Outcomes (2)

  • 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

  • Abnormal heart rhythms

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

    2 Weeks, 6 Weeks

Secondary Outcomes (1)

  • Functional mobility

    2 weeks, 4 weeks

Study Arms (2)

Interventional

EXPERIMENTAL

Pilates Clinical (Introductory program)

Other: Clinical Pilates

Control

ACTIVE COMPARATOR

Cardiac Rehabilitation

Other: Cardiac Rehabilitation

Interventions

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

Interventional

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

Control

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Hemodynamically stable patient Who underwent elective CABG.
  • Patients diagnosed with Kinesiophobia via Tampa scale for Kinesiophobia Heart (TSK-SV Heart)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lady Reading Hospital

Peshawar, KPK, 25000, Pakistan

Location

MeSH Terms

Conditions

Kinesiophobia

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mehwish Waseem, MSPT-CPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2024

First Posted

May 23, 2024

Study Start

February 15, 2024

Primary Completion

December 15, 2024

Study Completion

December 15, 2024

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations