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

University of Hail

Status: Completed

Conditions: Post-operative Breast Cancer

Treatments: Other: inspiratory muscle training; Other: Aerobic exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT06091696

H-2023-367

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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47 participants in 2 patient groups

study group

Experimental group

Description:

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.

Treatment:

Other: Aerobic exercises

Other: inspiratory muscle training

control group

Active Comparator group

Description:

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.

Treatment:

Other: Aerobic exercises