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SarcopeniaNCT02912130

Exercise and Nutrition Interventions in Age-related Sarcopenia

A study testing Protein Supplementation, Aerobic Exercise and Resistance Exercise in people with Sarcopenia and Muscular Atrophy, run by Liverpool Hope University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Sarcopenia, Muscular Atrophy
What is being tested?
Protein Supplementation, Aerobic Exercise and Resistance Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited Kingdom
Study dates
Sep 2016to Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male and Female participants
  • 60 - 90 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Liverpool Hope University

    Liverpool, Merseyside, L16 9JD

Other trials in United Kingdom

About this study

Official title: The Multidimensional Effects of Exercise and Nutritional Interventions on Musculoskeletal Functioning, Nutritional Status and Quality of Life in Age-related Sarcopenia

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.

Read the detailed description

Musculoskeletal ageing is an inevitable process associated with profound morphological and functional changes that will ultimately transition an individual from independent, to dependable living, relying heavily on personal health care for survival. The United Kingdom (UK) population aged over 65 years is expected to rise from 8.8 to 11.3 million by 2025. As life expectancy increases due to advances in medical treatment, an age-related disease termed sarcopenia, has become more prevalent in the elderly. Sarcopenia, described as the loss of musculoskeletal mass, strength and/or physical functioning with age, manifests after the 6th decade and rapidly increases after the 8th decade, resulting in a deterioration of health status and quality of life. To manage the looming health and economic consequences of sarcopenia, suitable therapeutic strategies to manage the condition are warranted. Therefore, this randomised control trial (RCT) will investigate the effects of 16-weeks of exercise and nutritional interventions in inactive senior citizens (60 - 90 years old).

Being tested
Protein Supplementation, Aerobic Exercise, Resistance Exercise
Keywords
Exercise, Nutrition, Sarcopenia, Healthy Ageing, Elderly, Muscular Hypertrophy
Medical subject headings
Sarcopenia, Muscular Atrophy, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Protein SupplementationDietary supplement

    1.2-1.5g/kg/body weight per day

  • Aerobic ExerciseOther

    30-60 minutes per week of moderate intensity exercise

  • Resistance ExerciseOther

    60 minutes per week of progressive resistance training

Study groups in NCT02912130
Study groupRoleWhat they receive
ControlNo interventionNo Intervention
ExerciseExperimental1. 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
Receives: Other: Aerobic Exercise; Other: Resistance Exercise
Exercise+NutritionExperimental1. 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
Receives: Dietary Supplement: Protein Supplementation; Other: Aerobic Exercise; Other: Resistance Exercise
NutritionExperimentalDietary Supplement: Protein Supplementation i.e. 1.2-1.5g/kg/body weight per day
Receives: Dietary Supplement: Protein Supplementation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 16 weeks

Secondary outcomes (19)
  1. Grip Strength: Hand Grip Dynanometer (kg)

    Measured: 16 weeks

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

    Measured: 16 Weeks

  3. Time to complete five chair rises (m/s)

    Measured: 16 Weeks

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

    Measured: 16 Weeks

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

    Measured: 16 Weeks

  6. Muscle Fatigue: Upper & Lower limb: 25% of MVC during 60 seconds using Electromyography (EMG), measured in millivolts (mV)

    Measured: 16 Weeks

  7. Exercise Tolerance: Six Minute Walk Test (metres)

    Measured: 16 Weeks

  8. 10-metre Gait analysis during habitual walking speed using Electromyography (EMG)

    Measured: 16 Weeks

  9. 10-metre Gait analysis during habitual walking speed using Three-Dimensional Motion Capture - 1) Spatiotemporal, 2) Kinematics

    Measured: 16 Weeks

  10. Biochemical: Glycated Haemoglobin (HBA1c) (%)

    Measured: 16 Weeks

  11. Biochemical: C-Reactive Protein (CRP) (mg/L)

    Measured: 16 Weeks

  12. Biochemical: Insulin-Like Growth Factor 1 (IGF-1) (ng/ml)

    Measured: 16 Weeks

  13. Arterial Pressure: Pulse Wave Velocity (m/s)

    Measured: 16 Weeks

  14. Energy Balance: Periodic Food Diary (Kcal)

    Measured: 16 Weeks

  15. World Health Organization Quality Of Life Assessment (WHOQOL): Each question is scored from 1-5 on a response scale

    Measured: 16 Weeks

  16. Short-Form Health Survey (SF-12): Each question is scored between 1-6 on a response scale

    Measured: 16 Weeks

  17. Activities of Daily Living (ADL): Each response is scored as either: 0 or 1

    Measured: 16 Weeks

  18. Mini-Mental State Examination (MMSE): Each correct response is scored as 1 point

    Measured: 16 Weeks

  19. Nutritional Status: Mini-Nutritional Assessment (MNA) - Classified as (Low, Moderate, High risk)

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionDec 2023
  4. Study completionDec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02912130
Sponsor's protocol ID
LiverpoolHU
Status last verified
Apr 2022
First submitted
12 Sep 2016
Last updated
11 Sep 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 20392703
  • 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.

    PubMed 27023595
  • 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.

    PubMed 25539836
  • 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.

    PubMed 26966433
  • 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.

    PubMed 26894275
  • 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.

    PubMed 26921660
  • 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.

    PubMed 26878863
  • 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.

    PubMed 26844538
  • 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.

    PubMed 26302881
  • 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.

    PubMed 25268791
  • 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.

    PubMed 25809808
  • 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.

    PubMed 20833863
  • 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.

    PubMed 34520104
  • 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.

    PubMed 31133863

Questions about this trial

What is this clinical trial studying?

A study testing Protein Supplementation, Aerobic Exercise and Resistance Exercise in people with Sarcopenia and Muscular Atrophy, run by Liverpool Hope University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02912130, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.

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