Clinical trial NCT06091696: The Effect of Inspiratory Muscle Training on Breast Cancer Patients Undergoing Surgery
Official title: The Effect of Inspiratory Muscle Training on Respiratory Muscle Strength, Functional Capacity, Fatigue, and Stress in Breast Cancer Patients Undergoing Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Breast Cancer
Lead sponsor: University of Hail
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 47
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a parallel model with 2 groups of study and control.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Inspiratory muscle strength by Maximal inspiratory pressure MIP
timeFrame: at baseline
measure: Inspiratory muscle strength by Maximal inspiratory pressure MIP
timeFrame: after the end of the treatment (after 8 weeks)
measure: Inspiratory muscle strength by Maximal inspiratory pressure MIP
timeFrame: at follow up (3 months after the end of the treatment)
measure: Functional exercise capacity evaluated by a 6-minute walk test (6MWT).
timeFrame: baseline
measure: Functional exercise capacity evaluated by a 6-minute walk test (6MWT).
timeFrame: after the end of the treatment (after 8 weeks)
measure: Functional exercise capacity evaluated by a 6-minute walk test (6MWT).
timeFrame: at follow up (3 months after the end of the treatment)
measure: Handgrip strength
timeFrame: at baseline
measure: Handgrip strength
timeFrame: after the end of the treatment (after 8 weeks)
measure: Handgrip strength
timeFrame: at follow up (3 months after the end of the treatment)
measure: Fatigue Assessment Scale (FAS)
timeFrame: baseline
measure: Fatigue Assessment Scale (FAS)
timeFrame: after the end of the treatment (after 8 weeks)
measure: Fatigue Assessment Scale (FAS)
timeFrame: at follow up (3 months after the end of the treatment)
measure: Perceived stress (Perceived Stress Scale pss 10)
timeFrame: baseline
measure: Perceived stress (Perceived Stress Scale pss 10)
timeFrame: after the end of the treatment (after 8 weeks)
measure: Perceived stress (Perceived Stress Scale pss 10)
timeFrame: at follow up (3 months after the end of the treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Hail
country: Saudi Arabia
facility: Hisham Hussein
Study officials:
References: