Concurrent Training and Nutritional Management in Cancer

NCT03720015 | Completed

• 1 other identifier: 0003
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

A case control study with before-after design. A concurrent training and a nutritional management intervention was offered by a patient with head and neck cancer, in order to compare outcomes related to strength and endurance performance and to body composition

Conditions

Body Weight Changes

Outcome Measures

Primary Outcomes (4)

• Body weight in kilograms (kg)

  8 weeks

• Total fat in percentage (%)

  8 weeks

• Lean body mass in percentage (%)

  8 weeks

• Visceral adipose tissue in cm2

  8 weeks

Secondary Outcomes (4)

• 1 repetition maximal (1RM) for upper-body in kilograms (kg)

  8 weeks

• 1 repetition maximal (1RM) for lower-body in kilograms (kg)

  8 weeks

• Maximal oxygen uptake (VO2max) in ml/kg/min

  8 weeks

• Power at VO2max in watts (W)

  8 weeks

Study Arms (2)

Concurrent training

EXPERIMENTAL

Three sessions per week of concurrent training during radiotherapy period. Each session will begin with warm-up (5-min cardiovascular activity at low-moderate intensity, joint mobility and one set of resistance exercises circuit at 30-40% 1RM). Resistance training will follow the warm-up, including 9 standard exercises involving major muscle groups of the lower and upper body: vertical bench press, parallel bar dip for triceps, seated rowing, standing dumbbell curl for biceps, leg press, deadlift and shoulder press. All these exercises will be realized following circuit training with 4 sets of 8-12 repetitions, using a training load of 70-80% RM. When patient will able to complete more than 12 repetitions, load will be increased progressively 10%. Cardiovascular training will be completed 20-30 min after resistance training, and it will include High-Intensity Interval Training (HIIT) of 3 min near to the second ventilatory threshold and 2 min near to the first ventilatory threshold.

Behavioral: Physical exercise

Nutritional management

EXPERIMENTAL

Prescribed diet controlling macronutrients according to patient body weight (\~4g/kg/day for carbohidrates, \~2g/kg/day for proteins, and \~1g/kg/day for fats). Patient will take one single dosage per day of probiotics (Arkoprobiotics® Defenses), 1 or 2 capsules of omega-3 fish oil concentrate (Solgar®, 600-1200mg depending on fat sources intake during the day), and a combine ingestion of 3g beta-hydroxybeta-methylbutyrate (HMB), 14g arginine, and 14g glutamine (HSN Raw Series®, all pure ingredients and making the ingestion adding each of them individually in a solution with 300-400 ml of water). During concurrent training sessions, between resistance exercise and HIIT, patient will also take 6g of BCAA's (HSN Raw Series®, 2:1:1) along with a banana. Additionally, patient could take whey isolated protein (Amix® IsoPrime CFM) to meet with some of the prescribed proteins intakes.

Dietary Supplement: Nutritional management

Interventions

Physical exercise BEHAVIORAL

Physical exercise controlled program supervised by an accredited exercise specialist

Concurrent training

Nutritional management DIETARY_SUPPLEMENT

Nutritional management controlled by a PhD clinical and sport nutrition specialist

Nutritional management

Eligibility Criteria

• Age: 32 Years - 34 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

This is a case control study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Universidad Francisco de Vitoria: lead

Study Sites (1)

Francisco de Vitoria University (UFV)

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

MeSH Terms

Conditions

Body Weight Changes

Interventions

Exercise; Diet

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Case study

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 25, 2018
• Study Start: July 20, 2017
• Primary Completion: July 24, 2017
• Study Completion: September 17, 2017
• Last Updated: November 29, 2018

Record last verified: 2018-11

Locations

ES (1)