Postural Management of Hyperkyphosis in Cardiac Rehab Patients

NCT06563882 | Completed

• 1 other identifier: 0172-23HMO
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the efficacy of a home-based exercise program in managing hyperkyphosis, and its impact on physical performance and pulmonary function among cardiac rehabilitation patients. The primary research question is: Can a home-based kyphosis-specific exercise program reduce thoracic hyperkyphosis and improve physical ability in cardiac patients undergoing cardiac rehabilitation? The study will consist of three groups: 1) Hyperkyphotic participants undergoing a 12-week exercise program at home, alongside a cardiac rehabilitation exercise program, 2) Hyperkyphotic participants solely undergoing cardiac rehabilitation exercise program, and 3) Participants without hyperkyphosis solely undergoing cardiac rehabilitation exercise program. The groups will be evaluated based on measurements of kyphosis index, physical performance and spirometry at the beginning, after 6 weeks, and upon completion of the 12-week program.

Conditions

Hyperkyphosis

Keywords

Home-based program; Graded exercise test; Spirometry; Flexicurve ruler; Six-minute walk test; Posture; Kyphosis index; Physical functional capacity; TUG test

Outcome Measures

Primary Outcomes (1)

• Degree of Kyphosis

  This measure will be obtained using a 60-centimeter flexicurve ruler, placed over the subject's back, from the C7 spinous process down to the T12 spinous process. Once attached to the back, the flexicurve molds according to its shape, allowing tracing of the thoracic curve onto paper. Maximum width and length measurements are then taken of the curve in centimeters in order to calculate the kyphosis index. Kyphosis index is calculated as the ratio of thoracic width to thoracic length. A higher index value indicates a greater degree of kyphosis, with values exceeding 13 considered hyperkyphosis. Assessment will occur at the program's start, after 6 weeks, and upon completion of the 12-week program.

  Assessment will occur at baseline, after 6 weeks, and upon completion of the 12-week program.

Secondary Outcomes (11)

• Maximum Metabolic Equivalents (METs)

  The measurement will be taken at baseline and upon completion of the 12-week program.

• Peak Heart Rate

  The measurement will be taken at baseline and upon completion of the 12-week program.

• Peak Systolic and Diastolic Blood Pressure

  The measurement will be taken at baseline and upon completion of the 12-week program.

• Distance covered in a six-minute walk test

  The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program.

• Time to complete the Five Times Sit to Stand Test (FTSST)

  The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program.

Study Arms (3)

Home-based exercise program

EXPERIMENTAL

Intervention Group: Hyperkyphotic participants will participate in a home exercise program designed to improve thoracic spine and shoulder mobility and flexibility, while also strengthening spine extensor muscles, alongside a cardiac rehabilitation exercise program. The home-based program will include six exercises to be performed three times a week over a period of 12 weeks.

Other: Home-based exercise program

Cardiac rehabilitation exercise program - Hyperkyphosis

OTHER

Control Group: Hyperkyphotic participants will participate in a 12-week cardiac rehabilitation exercise program, consisting of two one-hour sessions per week at the cardiac rehabilitation center. These sessions will include aerobic activity along with a variety of resistance, flexibility, and balance exercises.

Other: No intervention

cardiac rehabilitation exercise program - without hyperkyphosis

OTHER

Control Group: Participants without hyperkyphosis will participate in a 12-week cardiac rehabilitation exercise program, consisting of two one-hour sessions per week at the cardiac rehabilitation center. These sessions will include aerobic activity along with a variety of resistance, flexibility, and balance exercises.

Other: No intervention

Interventions

Home-based exercise program OTHER

The program will comprise of six exercises aimed at improving the mobility of the thoracic spine and shoulders, strengthening the extensor muscles of the spine, and enhancing the flexibility of the chest and anterior shoulders. Progression within the program will involve increasing exercise duration or repetitions/sets, along with implementing postural corrections in compound exercises. Participants will be instructed to perform the exercises at least three times a week. To heighten participants awareness of their daily posture, they will receive a daily scheduled message via WhatsApp reminding them to focus on their posture. Once a week, participants will be asked to submit a home exercise tracking report to monitor their adherence to the program. Additionally, exercises execution will be reviewed every two weeks, and adjustments to the program will be made accordingly.

Home-based exercise program

No intervention OTHER

No intervention

Cardiac rehabilitation exercise program - Hyperkyphosis; cardiac rehabilitation exercise program - without hyperkyphosis

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Heart patients who will be admitted for cardiac rehabilitation at Hadassah - Mount Scopus Hospital
• Normal stress test results.
• Independent mobility.
• Stable hemodynamic and respiratory status.
• Ability to speak and read basic Hebrewץ
• Ability to watch videos on a mobile phone or computer.
• Not receiving any other forms of physical therapy or physical treatment.

You may not qualify if:

• Presence of unstable angina.
• Neurological disorders or mental illnesses that interfere with communication.
• Movement disorders due to neurological disease.
• Severe orthopedic limitations hindering the execution of motor exercises.

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Zinman College of Physical Education and Sports Sciences: collaborator

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israek, 91120, Israel

Location

MeSH Terms

Conditions

Kyphosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2024
• First Posted: August 21, 2024
• Study Start: April 21, 2024
• Primary Completion: May 2, 2025
• Study Completion: May 2, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

IL (1)