Exercise and Nutrition Interventions in Age-related Sarcopenia

NCT02912130 | Completed DMC

• 1 other identifier: LiverpoolHU
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This project will investigate the synergistic effects of Aerobic and Resistance type Exercise, in combination with Protein Supplementation, on; Body Composition, Musculoskeletal Functioning, Nutritional Status and Quality of Life in Age-related Sarcopenia.

Conditions

Sarcopenia; Muscular Atrophy

Keywords

Exercise; Nutrition; Sarcopenia; Healthy Ageing; Elderly; Muscular Hypertrophy

Outcome Measures

Primary Outcomes (1)

• Body Composition: Lean Muscle/Fat Tissue 1) appendicular lean mass (kg) divided by height (meters-squared) and 2) appendicular lean mass divided by body mass index

  16 weeks

Secondary Outcomes (19)

• Grip Strength: Hand Grip Dynanometer (kg)

  16 weeks

• Gait speed during timed 4-meter walk (m/s)

  16 Weeks

• Time to complete five chair rises (m/s)

  16 Weeks

• Balance assessment: 1) feet side to side, 2) semi-tandem, 3) full tandem, and 4) single leg. Scored as Yes or No.

  16 Weeks

• Isometric Strength - Knee Flexion/Extension: Dynanometer (Nm/Kg)

  16 Weeks

Study Arms (4)

Control

NO INTERVENTION

No Intervention

Exercise

EXPERIMENTAL

1. Aerobic Exercise i.e. 30-60 minutes per week of moderate intensity exercise 2. Resistance Exercise i.e. 60 minutes per week of progressive resistance training

Other: Aerobic Exercise; Other: Resistance Exercise

Exercise+Nutrition

EXPERIMENTAL

1. Aerobic Exercise i.e. 30-60 minutes per week of moderate intensity exercise 2. Dietary Supplement i.e. Protein Supplementation 1.2-1.5g/kg/body weight per day

Dietary Supplement: Protein Supplementation; Other: Aerobic Exercise; Other: Resistance Exercise

Nutrition

EXPERIMENTAL

Dietary Supplement: Protein Supplementation i.e. 1.2-1.5g/kg/body weight per day

Dietary Supplement: Protein Supplementation

Interventions

Protein Supplementation DIETARY_SUPPLEMENT

1.2-1.5g/kg/body weight per day

Exercise+Nutrition; Nutrition

Aerobic Exercise OTHER

30-60 minutes per week of moderate intensity exercise

Exercise; Exercise+Nutrition

Resistance Exercise OTHER

60 minutes per week of progressive resistance training

Exercise; Exercise+Nutrition

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female participants
• years of age
• Resident in North West, England, UK
• BMI 18.5-30 kg/m
• Can speak and understand English
• Willing to consent and follow the study procedures

You may not qualify if:

• Recent (i.e. past 3 months) or concurrent participation in any clinical trial or dietary and/or exercise intervention program
• Self-reported lactose intolerance
• Uncontrolled diabetes (HbA1C \>10)
• Uncontrolled Hypertension (160/100) and uncontrolled hypotension (\<100 systolic)
• Treatment with Beta Blockers, Calcium Channel Blockers, Digitalis, Bronchodilator,
• Diuretics, Vasodilators
• Current hormone therapy such as insulin, testosterone or hormone replacement therapy
• History of falls/osteoporosis
• Major psychological/mental illness
• Medical conditions that precluded safe participation in an exercise program
• Other major systemic diseases: Liver and kidney diseases, Advanced gastrointestinal disorders, Cardiovascular Diseases, Advanced chronic obstructive pulmonary disease, Advanced Rheumatoid Arthritis, Cancer

Sponsors & Collaborators

• Liverpool Hope University: lead

Study Sites (1)

Liverpool Hope University

Liverpool, Merseyside, L16 9JD, United Kingdom

Location

Related Publications (14)

• Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.

  PMID: 20392703 BACKGROUND

• Witard OC, Wardle SL, Macnaughton LS, Hodgson AB, Tipton KD. Protein Considerations for Optimising Skeletal Muscle Mass in Healthy Young and Older Adults. Nutrients. 2016 Mar 23;8(4):181. doi: 10.3390/nu8040181.

  PMID: 27023595 BACKGROUND

• Lourenco RA, Perez-Zepeda M, Gutierrez-Robledo L, Garcia-Garcia FJ, Rodriguez Manas L. Performance of the European Working Group on Sarcopenia in Older People algorithm in screening older adults for muscle mass assessment. Age Ageing. 2015 Mar;44(2):334-8. doi: 10.1093/ageing/afu192. Epub 2014 Dec 23.

  PMID: 25539836 BACKGROUND

• Yu SC, Khow KS, Jadczak AD, Visvanathan R. Clinical Screening Tools for Sarcopenia and Its Management. Curr Gerontol Geriatr Res. 2016;2016:5978523. doi: 10.1155/2016/5978523. Epub 2016 Feb 4.

  PMID: 26966433 BACKGROUND

• Churchward-Venne TA, Holwerda AM, Phillips SM, van Loon LJ. What is the Optimal Amount of Protein to Support Post-Exercise Skeletal Muscle Reconditioning in the Older Adult? Sports Med. 2016 Sep;46(9):1205-12. doi: 10.1007/s40279-016-0504-2.

  PMID: 26894275 BACKGROUND

• Kraschnewski JL, Sciamanna CN, Poger JM, Rovniak LS, Lehman EB, Cooper AB, Ballentine NH, Ciccolo JT. Is strength training associated with mortality benefits? A 15year cohort study of US older adults. Prev Med. 2016 Jun;87:121-127. doi: 10.1016/j.ypmed.2016.02.038. Epub 2016 Feb 24.

  PMID: 26921660 BACKGROUND

• Witard OC, McGlory C, Hamilton DL, Phillips SM. Growing older with health and vitality: a nexus of physical activity, exercise and nutrition. Biogerontology. 2016 Jun;17(3):529-46. doi: 10.1007/s10522-016-9637-9. Epub 2016 Feb 15.

  PMID: 26878863 BACKGROUND

• Chang SF, Lin PL. Systematic Literature Review and Meta-Analysis of the Association of Sarcopenia With Mortality. Worldviews Evid Based Nurs. 2016 Apr;13(2):153-62. doi: 10.1111/wvn.12147. Epub 2016 Feb 4.

  PMID: 26844538 BACKGROUND

• Csapo R, Alegre LM. Effects of resistance training with moderate vs heavy loads on muscle mass and strength in the elderly: A meta-analysis. Scand J Med Sci Sports. 2016 Sep;26(9):995-1006. doi: 10.1111/sms.12536. Epub 2015 Aug 24.

  PMID: 26302881 BACKGROUND

• Xu ZR, Tan ZJ, Zhang Q, Gui QF, Yang YM. Clinical effectiveness of protein and amino acid supplementation on building muscle mass in elderly people: a meta-analysis. PLoS One. 2014 Sep 30;9(9):e109141. doi: 10.1371/journal.pone.0109141. eCollection 2014.

  PMID: 25268791 BACKGROUND

• Komar B, Schwingshackl L, Hoffmann G. Effects of leucine-rich protein supplements on anthropometric parameter and muscle strength in the elderly: a systematic review and meta-analysis. J Nutr Health Aging. 2015 Apr;19(4):437-46. doi: 10.1007/s12603-014-0559-4.

  PMID: 25809808 BACKGROUND

• Ko SU, Hausdorff JM, Ferrucci L. Age-associated differences in the gait pattern changes of older adults during fast-speed and fatigue conditions: results from the Baltimore longitudinal study of ageing. Age Ageing. 2010 Nov;39(6):688-94. doi: 10.1093/ageing/afq113. Epub 2010 Sep 10.

  PMID: 20833863 BACKGROUND

• Kirk B, Mooney K, Vogrin S, Jackson M, Duque G, Khaiyat O, Amirabdollahian F. Leucine-enriched whey protein supplementation, resistance-based exercise, and cardiometabolic health in older adults: a randomized controlled trial. J Cachexia Sarcopenia Muscle. 2021 Dec;12(6):2022-2033. doi: 10.1002/jcsm.12805. Epub 2021 Sep 14.

  PMID: 34520104 DERIVED

• Kirk B, Mooney K, Amirabdollahian F, Khaiyat O. Exercise and Dietary-Protein as a Countermeasure to Skeletal Muscle Weakness: Liverpool Hope University - Sarcopenia Aging Trial (LHU-SAT). Front Physiol. 2019 Apr 25;10:445. doi: 10.3389/fphys.2019.00445. eCollection 2019.

  PMID: 31133863 DERIVED

MeSH Terms

Conditions

Sarcopenia; Muscular Atrophy; Motor Activity

Interventions

Exercise; Resistance Training

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• Dr Omid Alizadehkhaiyat, MD, PhD

  Liverpool Hope University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 23, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 11, 2025

Record last verified: 2022-04

Locations

GB (1)