Impact of Resistance Training-Protein Supplementation on Lean Muscle Mass in Childhood Cancer Survivors

NCT02501460 | Completed

• 3 other identifiers: REPSAICR FDN YR 1NCI-2015-01152
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted because low lean muscle mass is prevalent among childhood cancer survivors. Lean muscle is the non-fatty muscle tissue that makes up part of the body's lean body mass. Low lean muscle mass is associated with loss of overall body strength, declining mobility and eventually, loss of independence. Among childhood cancer survivors, low lean muscle mass may contribute to reduced physical functioning and a sense of fatigue with exertion, limiting ability to participate in adequate physical activity. Loss of strength and a sense of fatigue with repeated movement make it difficult to participate in daily activities. Although there have not been exercise intervention studies among childhood cancer survivors specifically designed to evaluate the effects of resistance training on muscle mass, studies among individuals with chronic disease, including survivors of adult onset cancers, indicate that resistance exercise improves muscle mass, muscle strength, mobility, vitality and physical activity levels. Resistance training (weight lifting) is a form of physical activity that is designed to improve muscular fitness by exercising a muscle or a muscle group against external resistance. The purpose of the study is to evaluate the effects of resistance training combined with either a protein supplement or a sports drink on changes in lean muscle mass in young adults who were treated for childhood cancer. The sports drink, for this study, is considered a placebo.

Conditions

Cancer

Keywords

Adult cancer survivors; Exercise; Dietary supplementation

Outcome Measures

Primary Outcomes (15)

• Change in lean muscle mass by arm

  Dual x-ray absorptiometry (DEXA) will be used to determine lean muscle mass. Fat free mass will be measured in the total body scanning mode.

  Baseline and at 24 weeks

• Change in handgrip by arm

  Handgrip strength will be evaluated with a hand held dynamometer.

  Baseline and at 24 weeks

• Change in knee extension by arm

  Knee extension strength will be evaluated with the Biodex System IV dynamometer.

  Baseline and at 24 weeks

• Change in ankle dorsiflexion by arm

  Ankle dorsiflexion strength will be evaluated with the Biodex System IV dynamometer.

  Baseline and at 24 weeks

• Change in walking speed by arm

  Usual walking speed will be evaluated by having participants complete a timed 10 meter walk test.

  Baseline and at 24 weeks

• Change in endurance by arm

  Endurance will be evaluated by having participants complete the six minute walk test in a level of corridor as outlined by the American Thoracic Society.

  Baseline and at 24 weeks

• Change in activity level by arm

  Participants will complete the physical activity monitor (PAM) component of the most recent release of the National Health and Nutrition Examination Survey to measure activity levels. The PAM collects information on intensity and duration of common activities like walking and jogging for seven consecutive days. Participants will receive an accelerometer with written instructions, programmed to begin recording 12:01 a.m. on the day after the baseline assessment (the week before they begin training) and the day after their final training appointment.

  Baseline and at 24 weeks

• Change in blood pressure by arm

  Blood pressure will be evaluated with a sphygmomanometer.

  Baseline and at 24 weeks

• Change in high density lipoprotein by arm

  High density lipoprotein will be evaluated from fasting blood samples as part of a standard lipid panel.

  Baseline and at 24 weeks

• Change in triglycerides by arm

  Triglycerides will be evaluated from fasting blood samples as part of a standard lipid panel.

  Baseline and at 24 weeks

• Change in abdominal obesity by arm

  Abdominal obesity will be evaluated by measuring waist circumference with a Gulick tape measure to the nearest mm.

  Baseline and at 24 weeks

• Change in fasting glucose by arm

  Glucose level will be measured from fasting blood samples.

  Baseline and at 24 weeks

• Change in fasting insulin by arm

  Insulin level will be measure from fasting blood samples.

  Baseline and at 24 weeks

• Change in C-reactive protein by arm

  Highly sensitive C-reactive protein will be measured from fasting blood samples.

  Baseline and at 24 weeks

• Change in self-reported exhaustion by arm

  Measured using the vitality subscale of the Medical Outcomes Survey Short Form-36 (SF-36), version 2.

  Baseline and at 24 weeks

Study Arms (2)

Supplement Group

ACTIVE COMPARATOR

Participants will receive educational handouts and complete research testing to evaluate their physical condition prior to beginning the resistance training and dietary supplementation. Adherence will be assured as described below.

Other: Educational handouts; Other: Resistance training; Dietary Supplement: Supplementation

Placebo Group

PLACEBO COMPARATOR

Participants will receive educational handouts and complete research testing to evaluate their physical condition prior to beginning the resistance training and placebo. Adherence will be assured as described below.

Other: Educational handouts; Other: Resistance training; Other: Placebo

Interventions

Educational handouts OTHER

Both groups of participants will receive educational handouts that explain the Physical Activity Guidelines for Americans at enrollment.

Also known as: guidelines

Placebo Group; Supplement Group

Resistance training OTHER

Individuals in both groups will participate in an individually tailored progressive resistance training program 3 times/week for 24 weeks. During weeks 1-4 participants will be supervised twice a week tapering to once a week in weeks 5-12, every other week in weeks 13-20 and then once a month in weeks 21-24 by an American College of Sports Medicine (ACSM) Certified Exercise Specialist (trainer). Adherence: To assure fidelity and safety of the resistance training component of the intervention, participants will initially be supervised more frequently They will complete an exercise log for each of their sessions. As the supervision level for exercise is tapered, participants may receive reminders to exercise and take their supplement/placebo via text, phone, or e-mail as needed.

Also known as: exercise

Placebo Group; Supplement Group

Supplementation DIETARY_SUPPLEMENT

A medical quality protein supplement powder will be mixed with water or a sugar free drink mix to be taken daily within 60 minutes of training on exercise days or mid-morning on non-exercise days.

Also known as: protein dietary supplement

Supplement Group

Placebo OTHER

A placebo that appears to be identical to the medical quality protein supplement powder will be mixed with water or a sugar free drink mix to be taken daily within 60 minutes of training on exercise days or mid-morning on non-exercise days.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be enrolled on the SJLIFE protocol at St. Jude Children's Research Hospital.
• years of age
• \>10 years post first cancer diagnosis.
• English speaking.
• Live within a 45-minute drive of a greater Memphis area ATC Fitness Center
• Low lean mass defined as either:
• Age- and sex-specific relative lean muscle mass standard deviation score ≤ -1.0.
• Body fat content greater than or equal to 25% in males or greater than or equal to 35% in females.

You may not qualify if:

• Currently pregnant (assessed by serum pregnancy test).
• Contraindications to resistance training or protein supplementation (e.g. renal) verified by a physician.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• ATC Fitness: collaborator
• American Institute for Cancer Research: collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials open at St. Jude

MeSH Terms

Conditions

Neoplasms; Motor Activity

Interventions

Guidelines as Topic; Resistance Training; Exercise; Dietary Supplements

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kirsten K. Ness, PT, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 17, 2015
• Study Start: August 17, 2015
• Primary Completion: January 30, 2018
• Study Completion: January 30, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

US (1)