The Effect of Inspiratory Muscle Training on Breast Cancer Patients Undergoing Surgery

NCT ID: NCT06091696

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-17
• Study Completion Date: 2024-02-01

Brief Summary

This study will address the female patients who are exposed to surgery after breast cancer. strength training for the inspiratory muscles will be applied in addition to the traditional care including physical therapy that will be compared to the effect of the traditional care alone on multiple outcome measures such as muscle strength, function, fatigue, and stress.

Detailed Description

Saudi Arabia reported 24,485 new cases of cancer in 2018 with 10518 cancer deaths. There were genetic, hormonal, lifestyle, obesity, and environmental risk factors associated with different cancer types.

Many of the side effects of cancer and its treatments are burdensome and significantly impact the quality-of-life quality. Exercise before, during, and after cancer treatment provides numerous beneficial outcomes such as improving physical capacity, muscle power, and psychological status. Exercise is a valuable therapeutic tool for lowering acute, long-term, and late adverse effects of cancer.

For breast cancer patients, physiotherapy is a crucial component of treatment. The physical therapy exercise program helps patients regain fitness, reduce pain, and reduce side effects caused by different cancer treatment methods. Respiratory physiotherapy is a useful procedure for maintaining and improving functional capacity, quality of life, and post-treatment sequelae after breast cancer management, which is a combination of strategies aimed at preventing, treating, and stabilizing cardiorespiratory disorders in adults.

This study aimed to evaluate the effectiveness of inspiratory muscle training in post-surgical breast cancer survivors.

Conditions

Post-operative Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

study group

Inspiratory muscle training will be conducted using a pressure threshold loading device (Threshold Inspiratory Muscle Training, Respironics, Pittsburg, PA, USA). Using a spring-loaded one-way valve, this device provides air flow-independent resistance to inspiration at a detectable intensity. Patients will start training with a maximum inspiratory pressure (MIP) of 40%. The training intensity will be adjusted every week based on the MIP measurement.

Group Type: EXPERIMENTAL

inspiratory muscle training

Intervention Type: OTHER

inspiratory muscle training will be done by using a pressure threshold loading device (Threshold Inspiratory Muscle Training, Respironics, Pittsburg, PA, USA). By using a spring-loaded one-way valve, this device provides air flow-independent resistance to inspiration at a detectable intensity.

Aerobic exercises

Intervention Type: OTHER

Exercise training sessions under the supervision of an experienced physiotherapist were conducted for 30 minutes, 3 times per week, with intensity ranging between 13 and 15 on the rated perceived exertion scale (RPE).

control group

5 minutes of warming up and a similar time for cooling down in addition to light aerobic activity will be performed by the patients in both groups. Aerobic exercise training will be done through selected activities for 30 minutes /3 times per week for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Aerobic exercises

Intervention Type: OTHER

Exercise training sessions under the supervision of an experienced physiotherapist were conducted for 30 minutes, 3 times per week, with intensity ranging between 13 and 15 on the rated perceived exertion scale (RPE).

Interventions

inspiratory muscle training

inspiratory muscle training will be done by using a pressure threshold loading device (Threshold Inspiratory Muscle Training, Respironics, Pittsburg, PA, USA). By using a spring-loaded one-way valve, this device provides air flow-independent resistance to inspiration at a detectable intensity.

Intervention Type: OTHER

Aerobic exercises

Exercise training sessions under the supervision of an experienced physiotherapist were conducted for 30 minutes, 3 times per week, with intensity ranging between 13 and 15 on the rated perceived exertion scale (RPE).

Intervention Type: OTHER

Other Intervention Names

exercises

Eligibility Criteria

Inclusion Criteria

• Post-operative breast cancer female patients
• Age ≥40 years
• All patients with Eastern Cooperative Oncology Group performance status score ≤ 2
• Having to undergo primary treatment with surgery

Exclusion Criteria

• Severe anemia (Hb ≤ 8 g/dL)
• Presence of underlying chronic cardiac or respiratory disease
• severe infection, neurologic or muscular diseases prohibiting physical activity
• uncontrolled and/or extensive brain metastases, or bone metastases that were assessed to pose a risk of pathological fractures from exercising
• Contraindications descriped by the physician

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Hail

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdelmoniem Ibrahim

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hisham Hussein

Hail, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

H-2023-367

Identifier Type: -

Identifier Source: org_study_id