Clinical trial NCT04755465: Effects of NMES and Exercise in Hematological Cancer
Official title: Effects of Neuromuscular Electrical Stimulation Combined With Resistance Exercises on Muscle Strength in Adult Hematological Cancer Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Malignancy
Muscle Weakness
Keywords: Hematology
Therapeutic Electrical Stimulation
Exercise Therapy
Lead sponsor: Acibadem University
Sponsor class: OTHER
Collaborators: name: Medipol University
First posted: 2021-02-16
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Physical activity levels of adult hematologic cancer patients are deficient. The resulting physical inactivity causes fatigue, muscle loss, and deterioration in physical performance values. However, physical exercise programs still play a minor role in treating hematological malignancies. In addition, there are no reliable data in the literature regarding risk factors, feasibility, and exercise results in individuals with hematological malignancies. Although it is known that the use of corticosteroids, which are among the drugs given during chemotherapy, causes muscle weakness, there are no physical exercise programs performed with this patient group in the literature. The current study aims to compare the effects of resistance exercise and resistance exercise combined with neuromuscular electrical stimulation on muscle strength, functional lower extremity strength, and mobility in hematological cancer patients during chemotherapy.

Detailed description: Although people with hematological malignancies have to endure long stages of treatment and inactivity that are known to reduce their physical performance levels, it is still common practice to rest and avoid intense exercise. Although physical activity and exercise are important approaches to many diseases, their effects on cancer have been studied recently. There are still not enough studies in this area and it is not widely used. In recent studies, it is thought that exercise may benefit the symptoms that develop due to treatment in cancer patients. Even in the presence of severe muscle weakness and fatigue, skeletal muscle provides great adaptation when there is an appropriate exercise stimulus. In addition, exercise can increase immune functions, so it is thought that exercise practices in hematological cancer patients can specifically improve cellular functions such as microbial phagocytosis, T-cell proliferation, vaccine response, and killing tumor cells. There are various studies and approaches that try to create a different strategy and include physical exercise in the treatment strategy of hematological malignancies. These exercise programs generally include aerobics, flexibility, and resistance training methods. The necessity of developing alternative methods to exercise is emphasized in the literature due to the development of complications that affect participation in basic exercises such as walking. Resistance exercise training has been effective in improving muscle strength and endurance in cancer survivors, with most of the research on those with breast cancer, prostate cancer, and head and neck cancer. The number of studies providing strengthening training in patients with hematological cancer is limited. Neuromuscular electrical stimulation (NMES) has proven efficacy in improving muscle strength in a variety of populations. NMES training also has applicability for the cancer population to prevent treatment-related complications and improve health-related quality of life. However, there is still no high-level evidence to support the administration of NMES in cancer patients. In the present study, we aimed to evaluate the effect of resistance exercise improve muscle weakness in hematological cancer patients receiving intensive chemotherapy after HSCT. In addition, we aimed to evaluate the effect of resistance exercise and NMES training on fatigue, mobility, and quality of life in hematological cancer patients.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with hematological cancer,
* ≥ 18 years old
* ECOG Performance Status to be between 1-3
* Hemoglobin; 8-10gr / dl and over
* Receiving platelet support related to thrombocytopenia and/or having a platelet value of 20.000 mm3 or more
* Leukocyte (WBC) count being 3000 μL and above
* Giving written consent to participate in the study

Exclusion Criteria:

* Comorbidities that cause fatigue (eg multiple sclerosis, Parkinson's disease, heart failure)
* Presence of previously diagnosed heart disease
* Using a pacemaker
* Rapid deterioration of the general condition (sudden uncontrolled weight loss, confused consciousness, high C reactive protein (CRP) values)
* Brain metastasis or femoral bone metastasis
* Having dementia or psychotic condition
* Being depressed and /or taking medication to treat depression
* Presence of epilepsy
* Presence of neuropathy
* Having sensory defects in the NMES application area
* Denying NMES application

Primary outcomes:
measure: Muscle Strength Evaluation
timeFrame: Change from Baseline Muscle Strength through study completion, an average of 6 weeks
measure: Functional Muscle Strength Evaluation
timeFrame: Change from Baseline Functional Muscle Strength through study completion, an average of 6 weeks
Secondary outcomes:
measure: Anthropometric Assessment
timeFrame: Baseline and Immediately after completion of study, an average of 6 weeks
measure: Mobility Assessment
timeFrame: Baseline and Immediately after completion of study, an average of 6 weeks
measure: The Brief Fatigue Scale
timeFrame: Baseline and Immediately after completion of study, an average of 6 weeks
measure: European Cancer Research and Treatment Organization Quality of Life Questionnaire
timeFrame: Baseline and Immediately after completion of study, an average of 6 weeks
Other outcomes:
measure: Eastern Cooperative Oncology Group Performance Status Scale
timeFrame: Baseline and Immediately after completion of study, an average of 6 weeks
Locations:
city: Istanbul
country: Turkey
facility: Acibadem University
Study officials:
affiliation: Acibadem Healthcare Group
name: Ant Uzay, MD
role: STUDY_DIRECTOR
affiliation: Medipol University
name: Fatma Mutluay, Prof
role: STUDY_DIRECTOR
affiliation: Acibadem University
name: Elif Es Safran, MSc
role: PRINCIPAL_INVESTIGATOR
References: