- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04755465
Effects of NMES and Exercise in Hematological Cancer
Effects of Neuromuscular Electrical Stimulation Combined With Resistance Exercises on Muscle Strength in Adult Hematological Cancer Patients: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34752
- Acibadem University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Resistance Exercise Group
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.
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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.
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Experimental: NMES Training Group
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.
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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.
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Strength Evaluation
Time Frame: Change from Baseline Muscle Strength through study completion, an average of 6 weeks
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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.
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Change from Baseline Muscle Strength through study completion, an average of 6 weeks
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Functional Muscle Strength Evaluation
Time Frame: Change from Baseline Functional Muscle Strength through study completion, an average of 6 weeks
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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.
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Change from Baseline Functional Muscle Strength through study completion, an average of 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anthropometric Assessment
Time Frame: Baseline and Immediately after completion of study, an average of 6 weeks
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Thigh circumference measurement will be made from the middle of the thigh over the Quadriceps muscle.
By marking the inguinal region and the proximal part of the patella, the midpoint between the two points will be found.
All measurements will be made on the right side and by the same physiotherapist.
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Baseline and Immediately after completion of study, an average of 6 weeks
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Mobility Assessment
Time Frame: Baseline and Immediately after completion of study, an average of 6 weeks
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"Timed Up-Go Test" will be applied before and after treatment to evaluate the patient's mobility and functional exercise capacity.
The time taken to complete the task is strongly correlated with the level of functional mobility.
In other words, the longer the person completes the task, the more dependent he is on daily life activities.
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Baseline and Immediately after completion of study, an average of 6 weeks
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The Brief Fatigue Scale
Time Frame: Baseline and Immediately after completion of study, an average of 6 weeks
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The Brief Fatigue Scale will be used to assess cancer-related fatigue in our study.
This scale is one of the standard tests used to evaluate fatigue in cancer patients.
Evaluates the level of fatigue in the last 24 hours and the effect of fatigue on daily activities (general activity, mood, walking ability, work life, relationships with other people, joy of life)
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Baseline and Immediately after completion of study, an average of 6 weeks
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European Cancer Research and Treatment Organization Quality of Life Questionnaire
Time Frame: Baseline and Immediately after completion of study, an average of 6 weeks
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The assessment of quality of life will be carried out using the European Cancer Research and Treatment Organization Quality of Life Questionnaire Version 3.0.
The scale consists of three subsections: general health status scale, functional scale, and symptom scale, and includes a total of 30 questions.
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Baseline and Immediately after completion of study, an average of 6 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eastern Cooperative Oncology Group Performance Status Scale
Time Frame: Baseline and Immediately after completion of study, an average of 6 weeks
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An overall assessment of activity level will be based on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale based on the degree of muscle weakness found in the Cancer Treatment Evaluation Program Common Toxicity Criteria, and patients with an ECOG performance status of 1-3 will be treated.
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Baseline and Immediately after completion of study, an average of 6 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Ant Uzay, MD, Acibadem Healthcare Group
- Study Director: Fatma Mutluay, Prof, Medipol University
- Principal Investigator: Elif Es Safran, MSc, Acibadem University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-16/10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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