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

Official title

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

Overview

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.

Interventions

• 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
• 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 sess
• 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
• 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

Primary outcome measures

• Muscle strength [Time frame: 12 weeks]

Secondary outcome measures (12)

• Muscle Mass [Time frame: 12 weeks]
• Fat Mass [Time frame: 12 weeks]
• Total Body Water [Time frame: 12 weeks]
• Cardiorespiratory Fitness (CRF) [Time frame: 12 weeks]
• Inflammation status [Time frame: 12 weeks]
• Patient-reported performance status-1 [Time frame: 12 weeks]
• Patient-reported performance status-2 [Time frame: 12 weeks]
• Patient-reported Quality of Life (QoL) [Time frame: 12 weeks]
• Patient-reported Fatigue [Time frame: 12 weeks]
• Patient-reported Physical Activity [Time frame: 12 weeks]
• Objective Physical Activity [Time frame: 12 weeks]
• Cardiometabolic Risk Profile (Metabolic Syndrome Z-Score, MetS) [Time frame: 12 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Germany · 1 center

• Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports — Erlangen

Publications

• Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518. PMID 39606939

Identifiers

NCT: NCT04067167 · FREEDOM-Study

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗