Effects of NMES and Exercise in Hematological Cancer

Acibadem University

Status: Completed

Conditions: Hematologic Malignancy; Muscle Weakness

Treatments: Other: Structured Exercise; Device: Neuromuscular Electrical Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04755465

2020-16/10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 2 patient groups

Resistance Exercise Group

Experimental group

Description:

The lower extremity resistance exercise (REx) program was designed by reviewing the exercise principles recommended by the ACSM and the literature on physical activity and hematological cancer patients. The patients were treated for 40-60mins, 6 weeks. The exercise program includes active movements of the upper and lower extremities, stretching exercises, and resistance exercises for the lower extremities. REx to be applied with resistance bands of different resistance or with the patient's body weight. Clinical force generation of therapy bands follows a progression. Our proposed training protocol includes 4-6 different exercises for each extremity. Intensity, sets, and reps were adjusted to a target score of 12 to 14 using the Borg scale. Patients performed 1 set of 10 repetitions of each REx based on their fatigue level. Intensity (\~ RPE 15-16) and resistance were gradually increased. When the patient complained of extreme fatigue, the resistance was reduced to the previous level.

Treatment:

Other: Structured Exercise

NMES Training Group

Experimental group

Description:

In addition to resistance exercises, NMES will be applied to the quadriceps muscles in both legs of the patients in this group. The application will be made with a portable device using disposable electrodes. One of the electrodes will be placed proximally, that is, at the midpoint of the quadriceps muscle, while the second electrode will be placed on the distal part. In order to ensure that the patients get used to the device, low-intensity current with a frequency range of 5 Hz, 10-30 minutes. Afterward, the treatment program will continue with a high-frequency current with a frequency range of 50 Hz, 15 minutes. Participants were instructed to voluntarily contract the quadriceps muscles during periods of HF-NMES stimulation to increase the strengthening effect and improve NMES tolerance.

Treatment:

Other: Structured Exercise

Device: Neuromuscular Electrical Stimulation