Effects of NMES and Exercise in Hematological Cancer

NCT04755465 | Completed

• 1 other identifier: 2020-16/10
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignancy; Muscle Weakness

Keywords

Hematology; Therapeutic Electrical Stimulation; Exercise Therapy

Outcome Measures

Primary Outcomes (2)

• Muscle Strength Evaluation

  Participants' muscle strength measurements will be made using a digital hand dynamometer (J Tech Commander Muscle Tester). The patients will be seated in the appropriate position and the dynamometer will be placed in the dominant leg to give resistance to the muscle to be evaluated. While patients press the dynamometer as hard as possible for three seconds, the evaluator will give resistance to prevent any movement to provide an isometric contraction. Following the familiarization test, patients will perform three trials with standardized verbal encouragement and the highest strength (kilogram, kg) sustained for over half a second will be recorded.

  Change from Baseline Muscle Strength through study completion, an average of 6 weeks

• Functional Muscle Strength Evaluation

  Lower extremity functional strength will be evaluated using the "Sit and Stand for 30 sec" test. The patient will be instructed to stand up and sit back and forth from a standardized chair as quickly as possible in 30 seconds without using his arms. Participants will be able to use their hands to help them stand as needed, and standardized verbal encouragement will be provided to continue sitting and standing throughout the test.

  Change from Baseline Functional Muscle Strength through study completion, an average of 6 weeks

Secondary Outcomes (4)

• Anthropometric Assessment

  Baseline and Immediately after completion of study, an average of 6 weeks

• Mobility Assessment

  Baseline and Immediately after completion of study, an average of 6 weeks

• The Brief Fatigue Scale

  Baseline and Immediately after completion of study, an average of 6 weeks

• European Cancer Research and Treatment Organization Quality of Life Questionnaire

  Baseline and Immediately after completion of study, an average of 6 weeks

Other Outcomes (1)

• Eastern Cooperative Oncology Group Performance Status Scale

  Baseline and Immediately after completion of study, an average of 6 weeks

Study Arms (2)

Resistance Exercise Group

EXPERIMENTAL

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.

Other: Structured Exercise

NMES Training Group

EXPERIMENTAL

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.

Device: Neuromuscular Electrical Stimulation; Other: Structured Exercise

Interventions

Neuromuscular Electrical Stimulation DEVICE

Neuromuscular Electrical Stimulation (NMES) is based on the principle of creating a contraction by stimulating the nerve fibers innervating the related muscle in the healthy muscle and the muscle fibers in the denervated muscle with electrical current. The electric currents used in stimulation of muscles and nerves perform this function by changing the electrical potential of cell membranes. It is contraindicated in pregnancy, presence of pacemaker, severe heart disease, epilepsy, fracture, dementia and impaired consciousness. We prevent contraindicated situations by excluding volunteer participants with these characteristics.

NMES Training Group

Structured Exercise OTHER

Warm-up exercise, main training program and cool down exercise. Main training consists of resistance exercises to be applied with resistance bands of different resistance or with the patient's own body weight. Our prescribed training protocol includes 4-6 different exercises for each limb (bench press with resistance band, upper extremity proprioceptive neuromuscular facilitation exercises, biceps/triceps curl, leg press, knee extension, 4-way hip motion, mini squat). Intensity, sets, and number of repetitions will be adapted to a target score between 12 and 14 using the Borg scale. It will be applied as low intensity, long-term passive stretching exercises to the pectoral, hamstring, and gastrosoleus muscle groups. Patients will perform 1 set of 10 repetitions of each resistance exercise determined by their level of fatigue. Resistance will be increased every three visits. If the patient complains of excessive fatigue, the resistance will be reduced to the previous level.

NMES Training Group; Resistance Exercise Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead
• Medipol University: collaborator

Study Sites (1)

Acibadem University

Istanbul, 34752, Turkey (Türkiye)

Location

Related Publications (1)

• Safran EE, Mutluay F, Uzay A. Effects of neuromuscular electrical stimulation combined with resistance exercises on muscle strength in adult hematological cancer patients: A randomized controlled study. Leuk Res. 2022 Oct;121:106932. doi: 10.1016/j.leukres.2022.106932. Epub 2022 Aug 22.

  PMID: 36027848 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms; Muscle Weakness

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Ant Uzay, MD

  Acibadem Healthcare Group

  STUDY DIRECTOR

• Fatma Mutluay, Prof

  Medipol University

  STUDY DIRECTOR

• Elif Es Safran, MSc

  Acibadem University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: February 16, 2021
• Study Start: February 8, 2021
• Primary Completion: November 30, 2021
• Study Completion: December 6, 2021
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)