Development and Validation of MPF to Prevent and Mitigate Postural Hyperkyphosis in Postmenopausal Women

NCT ID: NCT07068360

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-17
• Study Completion Date: 2026-06-01

Brief Summary

Postural hyperkyphosis is common in postmenopausal women and leads to spinal dysfunction, pain, impaired balance, and increased fall risk. This study aims to develop and validate a multimodal physiotherapy framework to prevent and manage hyperkyphosis in this population. A randomized controlled trial will be conducted at Allied Hospital with 72 postmenopausal women aged 40-75 years, divided into intervention (multimodal physiotherapy with conventional care) and control (conventional care only) groups.

Detailed Description

The intervention includes strength, flexibility, postural correction, and balance training. The primary outcome is the change in Cobb's angle measured via radiographs; secondary outcomes include functional mobility and balance assessments using the Timed Up and Go Test, Berg Balance Scale, and Functional Reach Test. Data will be analyzed using SPSS v26. The study is expected to show significant improvements in spinal alignment, strength, balance, and reduced fall risk. The framework may offer a cost-effective, evidence-based approach for clinical and community rehabilitation

Conditions

Hyperkyphosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Strength Training +Postural Correction Exercises + Balance Training +Flexibility Exercises

Group Type: EXPERIMENTAL

Strength Training +Postural Correction Exercises + Balance Training +Flexibility Exercises

Intervention Type: COMBINATION_PRODUCT

Interventions details (Group A) Strength Training Postural Correction Exercises Balance Training Exercises

Flexibility Exercises:

Standard Intervention (Control Group)

Group Type: ACTIVE_COMPARATOR

Standard Intervention (Control Group)

Intervention Type: DIAGNOSTIC_TEST

The control group will receive standard physiotherapy for postural hyperkyphosis.

The standard intervention will consist of:

Postural education: Educating participants on proper posture, body mechanics, and ergonomics in daily activities.

Basic stretching exercises targeting the thoracic spine and back muscles. Recommendations for low-impact aerobics activities (e.g., walking or cycling) to promote overall healthThe standard intervention will be delivered over the same 12-week period, with two sessions per week. This group will not receive the integrated multimodal framework with strength training, postural correction, balance training, and flexibility exercises that the experimental group receives. Duration and Frequency

Interventions

Strength Training +Postural Correction Exercises + Balance Training +Flexibility Exercises

Interventions details (Group A) Strength Training Postural Correction Exercises Balance Training Exercises

Flexibility Exercises:

Intervention Type: COMBINATION_PRODUCT

Standard Intervention (Control Group)

The control group will receive standard physiotherapy for postural hyperkyphosis.

The standard intervention will consist of:

Postural education: Educating participants on proper posture, body mechanics, and ergonomics in daily activities.

Basic stretching exercises targeting the thoracic spine and back muscles. Recommendations for low-impact aerobics activities (e.g., walking or cycling) to promote overall healthThe standard intervention will be delivered over the same 12-week period, with two sessions per week. This group will not receive the integrated multimodal framework with strength training, postural correction, balance training, and flexibility exercises that the experimental group receives. Duration and Frequency

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Postmenopausal women aged 50-70 years.
• Kyphotic angle ≥40°, as measured by a flexicurve ruler or radiographic assessment.
• Postmenopausal for at least one year.
• Able to engage in rehabilitation exercises and follow instructions for physical activity..
• Living independently and capable of attending regular physiotherapy sessions.

Exclusion Criteria

• Uncontrolled comorbidities such as cardiovascular disease, neurological disorders stroke or Parkinson's), or severe musculoskeletal conditions (e.g., advanced arthritis )
• History of spinal surgery within the last 6 months or spinal surgical implants. Severe osteoporosis (T-score < -2.5) and a history of multiple fractures.
• Pregnant or breastfeeding women. Cognitive impairments or mental health disorders that hinder adherence to the intervention.
• Inability to perform the exercises due to pain or disability.
• Participation in other rehabilitation or physiotherapy interventions for postural hyperkhyposis

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faisalabad Medical University (Allied Hospital Faisalabad)

Faisalābad, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

PhDRSW/Batch-Fall23/2224

Identifier Type: -

Identifier Source: org_study_id