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Completed

NCT Number: NCT02912130

Exercise and Nutrition Interventions 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.

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Key information

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liverpool Hope University

Liverpool, Merseyside, L16 9JD, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Protein supplementation

Dietary Supplement

1.2-1.5g/kg/body weight per day

Aerobic Exercise

Other

30-60 minutes per week of moderate intensity exercise

Resistance Exercise

Other

60 minutes per week of progressive resistance training

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

    Time frame: 16 weeks

Secondary outcomes

  1. Grip Strength: Hand Grip Dynanometer (kg)

    Time frame: 16 weeks

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

    Time frame: 16 Weeks

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

    Time frame: 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.

    Time frame: 16 Weeks

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

    Time frame: 16 Weeks

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

    Time frame: 16 Weeks

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

    Time frame: 16 Weeks

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

    Time frame: 16 Weeks

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

    Time frame: 16 Weeks

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

    Time frame: 16 Weeks

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

    Time frame: 16 Weeks

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

    Time frame: 16 Weeks

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

    Time frame: 16 Weeks

  14. Energy Balance: Periodic Food Diary (Kcal)

    Time frame: 16 Weeks

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

    Time frame: 16 Weeks

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

    Time frame: 16 Weeks

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

    Time frame: 16 Weeks

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

    Time frame: 16 Weeks

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

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Liverpool Hope University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Sep 23, 2016
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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