Flexi Band Resistance Training Versus EMS Exercise in Patients With the Diagnosis of Malignant Diseases (FREEDOM)

Effects of Flexi Band Resistance Training Versus Different Electromyostimulation Exercise Programs in Patients With the Diagnosis of Malignant Diseases

The purpose of this study is to investigate the effects of a 12-week flexi band resistance training program compared to different whole-body electromyostimulation (WB-EMS) exercise programs on muscle strength, body composition (in particular muscle mass), cardiorespiratory fitness, inflammation, and patient-reported subjective outcomes (e.g. quality of life, fatigue, performance status) in patients with malignant disease undergoing curative or palliative anti-cancer treatment.

Study Overview

• Status: Unknown
• Conditions: Inflammation; Cancer; Muscular Atrophy; Cancer Cachexia
• Intervention / Treatment: Other: WB-EMS (Sham-intervention); Other: WB-EMS; Other: Free WB-EMS; Other: Flexi band resistance training

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hans Joachim Herrmann, Dr.; Phone Number: +49 9131 8545218; Email: hans.herrmann@uk-erlangen.de
• Study Contact Backup: Name: Yurdagül Zopf, Prof.; Phone Number: +49 9131 8545218; Email: yurdaguel.zopf@uk-erlangen.de

Study Locations

• Germany
  • Erlangen, Germany, 91054
    • Recruiting
    • Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports
    • Contact: Hans Joachim Herrmann, Dr.; Phone Number: +49 9131 8545218; Email: hans.herrmann@uk-erlangen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• malignant disease (solid or hematological cancer): head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma, lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas or Graft-versus-Host-Disease after bone marrow transplantation
• ongoing or planned curative or palliative anti-cancer therapy
• ECOG-Status 0-2

Exclusion Criteria:

• simultaneous participation in other nutritional or exercise intervention Trials
• bone metastases with high fracture risk
• cardiovascular disease
• use of anabolic medications
• epilepsy
• severe neurological or rheumatic diseases
• skin lesions in the area of electrodes
• energy active metals in body
• pregnancy
• acute vein thrombosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: WB-EMS (Sham-intervention); Low-theshold WB-EMS combined with nutritional therapy	Other: WB-EMS (Sham-intervention); Whole-Body Electromyostimulation (WB-EMS): WB-EMS with low-threshold stimulation during a study period of 12 weeks combined with standard nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted Protein intake/day: 1.2 - 1.5 g per kg bodyweight); patients perform simple exercises during the stimulation period following a video tutorial; time-effort per session: ~20 min; 2 training sessions per week
Experimental: WB-EMS; WB-EMS combined with nutritional therapy	Other: WB-EMS; Whole-Body Electromyostimulation (WB-EMS): WB-EMS during study period of 12 weeks combined with standard nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted Protein intake/day: 1.2 - 1.5 g per kg bodyweight); WB-EMS stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec;; patients perform simple exercises during the stimulation period following a video tutorial; time-effort per session: ~20 min; 2 training sessions per week
Experimental: Free WB-EMS; WB-EMS using a mobile System combined with nutritional therapy	Other: Free WB-EMS; Whole-Body Electromyostimulation (WB-EMS) using a mobile system: WB-EMS during study period of 12 weeks combined with standard nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted Protein intake/day: 1.2 - 1.5 g per kg bodyweight); WB-EMS stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec;; patients perform simple exercises during the stimulation period following a video tutorial; time-effort per session: ~20 min; 2 training sessions per week
Experimental: Flexi Band Resistance Training; Flexi band resistance Training combined with nutritional therapy	Other: Flexi band resistance training; Flexi band resistance Training: Training during study period of 12 weeks combined with standard nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted Protein intake/day: 1.2 - 1.5 g per kg bodyweight); patients perform resistance exercises using flexi bands; flexi band exercises are conceptualized to activate similar muscle groups as EMS exercise; time-effort per session: ~20 min; 2 training sessions per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength	Muscle strength of the five major muscle groups (chest, upper back, lower back, abdominals, legs) will be assessed by using specific strength-training devices and estimated using the one Repetition Maximum (1-RM, the maximum amount of weight [kg] that can be lifted for one repetition)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Mass	Muscle mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)	12 weeks
Fat Mass	Fat mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)	12 weeks
Total Body Water	Total body water (L) will be measured by Bioelectrical Impedance Analysis (BIA)	12 weeks
Cardiorespiratory Fitness (CRF)	CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)	12 weeks
Inflammation status	Inflammation will be assessed by measuring blood levels (mg/L) of c-reactive protein (CRP) and high-sensitivity c-reactive protein (hs-CRP).	12 weeks
Patient-reported performance status-1	Patient-reported performance Status will be assessed using the ECOG Performance Status questionnaire. It describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability. The score ranges from 0-5 (lower values = better outcome).	12 weeks
Patient-reported performance status-2	Patient-reported performance status-2 will be assessed using the Karnofsky index. It is used methods to assess the functional status of a Patient. The score ranges from 0-100 (higher value = better outcome).	12 weeks
Patient-reported Quality of Life (QoL)	Patient-reported QoL will be assessed using the EORTC QLQ-C30 questionnaire. It contains 30 questions (items), representing various aspects/dimensions of QoL (physical, role, emotional, cognitive and social), and 3 symptom scales (fatigue, pain and nausea).The scales of the different dimensions of QoL (higher values = better outcome) and symptoms (lower values = better outcomes) range from 0-100.	12 weeks
Patient-reported Fatigue	Fatigue will be assessed using the FACIT-Fatigue scale. It contains 13 items (different aspects/dimensions of fatigue) each assessed on a scale of 0-4, with lower values indicating a better outcome).	12 weeks
Patient-reported Physical Activity	Patient-reported Physical Activity (PA) will be assessed using the the International Physical Activity Questionnaire (IPAQ). IPAQ records 4 aspects of PA (job-, transportation-, housework-, and leisure-time-related). There are two forms of output from scoring the IPAQ. Results can be reported in categories (low, moderate or high PA levels) or as a continuous variable (MET minutes a week, 1 MET = resting energy expenditure). MET minutes represent the amount of energy expended carrying out physical activity. High PA = at least 1500 MET minutes/week; moderate PA: at least 600 MET minutes/week; low PA: < 600 MET minutes/week. Higher values represent a better outcome.	12 weeks
Objective Physical Activity	Obejective measurement of physical activity will be preformed using Pedometers. Higher values represent a better outcome.	12 weeks
Cardiometabolic Risk Profile (Metabolic Syndrome Z-Score, MetS)	MetS will be calculated MetS-Z-Score will be calculated from each individual's measures of waist circumference (cm), mean arterial blood pressure (mmHg), blood levels of glucose (mg/dL), triglycerides (mg/dL), and HDL-cholesterol (mg/dL), based on equations specific to sex.	12 weeks

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 26, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Cancer; Nutrition; Body composition; Physical exercise; Cachexia; whole-body electromyostimulation; Muscle mass; Resistance training; Muscular strength
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Nutrition Disorders; Body Weight; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Body Weight Changes; Atrophy; Emaciation; Weight Loss; Inflammation; Muscular Atrophy; Wasting Syndrome; Cachexia
• Other Study ID Numbers: FREEDOM-Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No