Back to resultsFlexi Band Resistance Training Versus EMS Exercise in Patients With the Diagnosis of Malignant Diseases (FREEDOM)
Primary Purpose
Cancer, Cancer Cachexia, Inflammation
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
WB-EMS (Sham-intervention)
WB-EMS
Free WB-EMS
Flexi band resistance training
Sponsored by
About this trial
This is an interventional treatment trial for Cancer focused on measuring Cancer, Cachexia, Muscular strength, Resistance training, Body composition, Muscle mass, Physical exercise, Nutrition, whole-body electromyostimulation
Eligibility Criteria
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
Sites / Locations
- Department of Medicine 1, Hector-Center for Nutrition, Exercise and SportsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Sham Comparator
Experimental
Experimental
Experimental
Arm Label
WB-EMS (Sham-intervention)
WB-EMS
Free WB-EMS
Flexi Band Resistance Training
Arm Description
Low-theshold WB-EMS combined with nutritional therapy
WB-EMS combined with nutritional therapy
WB-EMS using a mobile System combined with nutritional therapy
Flexi band resistance Training combined with nutritional therapy
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Muscle Mass
Muscle mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)
Fat Mass
Fat mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)
Total Body Water
Total body water (L) will be measured by Bioelectrical Impedance Analysis (BIA)
Cardiorespiratory Fitness (CRF)
CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)
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).
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).
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).
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.
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).
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.
Objective Physical Activity
Obejective measurement of physical activity will be preformed using Pedometers. Higher values represent a better outcome.
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.
Full Information
NCT ID
NCT04067167
First Posted
May 15, 2019
Last Updated
August 21, 2019
Sponsor
University of Erlangen-Nürnberg Medical School
1. Study Identification
Unique Protocol Identification Number
NCT04067167
Brief Title
Flexi Band Resistance Training Versus EMS Exercise in Patients With the Diagnosis of Malignant Diseases
Acronym
FREEDOM
Official Title
Effects of Flexi Band Resistance Training Versus Different Electromyostimulation Exercise Programs in Patients With the Diagnosis of Malignant Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Cancer Cachexia, Inflammation, Muscular Atrophy
Keywords
Cancer, Cachexia, Muscular strength, Resistance training, Body composition, Muscle mass, Physical exercise, Nutrition, whole-body electromyostimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment parallel-group, randomized-controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
WB-EMS (Sham-intervention)
Arm Type
Sham Comparator
Arm Description
Low-theshold WB-EMS combined with nutritional therapy
Arm Title
WB-EMS
Arm Type
Experimental
Arm Description
WB-EMS combined with nutritional therapy
Arm Title
Free WB-EMS
Arm Type
Experimental
Arm Description
WB-EMS using a mobile System combined with nutritional therapy
Arm Title
Flexi Band Resistance Training
Arm Type
Experimental
Arm Description
Flexi band resistance Training combined with nutritional therapy
Intervention Type
Other
Intervention Name(s)
WB-EMS (Sham-intervention)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
WB-EMS
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Free WB-EMS
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Flexi band resistance training
Intervention Description
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
Primary Outcome Measure Information:
Title
Muscle strength
Description
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)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Muscle Mass
Description
Muscle mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)
Time Frame
12 weeks
Title
Fat Mass
Description
Fat mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)
Time Frame
12 weeks
Title
Total Body Water
Description
Total body water (L) will be measured by Bioelectrical Impedance Analysis (BIA)
Time Frame
12 weeks
Title
Cardiorespiratory Fitness (CRF)
Description
CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)
Time Frame
12 weeks
Title
Inflammation status
Description
Inflammation will be assessed by measuring blood levels (mg/L) of c-reactive protein (CRP) and high-sensitivity c-reactive protein (hs-CRP).
Time Frame
12 weeks
Title
Patient-reported performance status-1
Description
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).
Time Frame
12 weeks
Title
Patient-reported performance status-2
Description
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).
Time Frame
12 weeks
Title
Patient-reported Quality of Life (QoL)
Description
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.
Time Frame
12 weeks
Title
Patient-reported Fatigue
Description
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).
Time Frame
12 weeks
Title
Patient-reported Physical Activity
Description
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.
Time Frame
12 weeks
Title
Objective Physical Activity
Description
Obejective measurement of physical activity will be preformed using Pedometers. Higher values represent a better outcome.
Time Frame
12 weeks
Title
Cardiometabolic Risk Profile (Metabolic Syndrome Z-Score, MetS)
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hans Joachim Herrmann, Dr.
Phone
+49 9131 8545218
Email
hans.herrmann@uk-erlangen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Yurdagül Zopf, Prof.
Phone
+49 9131 8545218
Email
yurdaguel.zopf@uk-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dejan Reljic, Dr.
Organizational Affiliation
University Erlangen Nuremberg Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yurdagül Zopf, Prof.
Organizational Affiliation
University Erlangen Nuremberg Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans Joachim Herrmann, Dr.
Phone
+49 9131 8545218
Email
hans.herrmann@uk-erlangen.de
First Name & Middle Initial & Last Name & Degree
Dejan Reljic, Dr.
Phone
+49 9131 8545218
Email
dejan.reljic@uk-erlangen.de
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Flexi Band Resistance Training Versus EMS Exercise in Patients With the Diagnosis of Malignant Diseases
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