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Exercise and Nutrition Interventions in Age-related Sarcopenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02912130
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Omid Alizadehkhaiyat, Liverpool Hope University

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.

Condition or disease Intervention/treatment Phase
Sarcopenia Muscular Atrophy Dietary Supplement: Protein Supplementation Other: Aerobic Exercise Other: Resistance Exercise Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Multidimensional Effects of Exercise and Nutritional Interventions on Musculoskeletal Functioning, Nutritional Status and Quality of Life in Age-related Sarcopenia
Actual Study Start Date : September 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
No Intervention
Experimental: Exercise
  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
30-60 minutes per week of moderate intensity exercise

Other: Resistance Exercise
60 minutes per week of progressive resistance training

Experimental: Exercise+Nutrition
  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
1.2-1.5g/kg/body weight per day

Other: Aerobic Exercise
30-60 minutes per week of moderate intensity exercise

Other: Resistance Exercise
60 minutes per week of progressive resistance training

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912130


Contacts
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Contact: Dr Omid Alizadehkhaiyat, MD, PhD (+44) 0151 291 3262 alizado@hope.ac.uk
Contact: Dr Farzad Amirabdhollahian, PhD (+44) 0151 291 3799 amirabf@hope.ac.uk

Locations
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United Kingdom
Liverpool Hope University Recruiting
Liverpool, Merseyside, United Kingdom, L16 9JD
Contact: Ben Kirk, BSc, MSc    (+44) 0151 291 3815    kirkb@hope.ac.uk   
Contact: Kate Mooney, BSc, MSc    (+44) 0151 291 3815    mooneyk1@hope.ac.uk   
Sub-Investigator: Ben Kirk, BSc, MSc         
Sub-Investigator: Kate Mooney, BSc, MSc         
Principal Investigator: Omid Alizadehkhaiyat, MD, PhD         
Principal Investigator: Farzad Amirabdollahian, PhD         
Sponsors and Collaborators
Liverpool Hope University
Investigators
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Principal Investigator: Dr Omid Alizadehkhaiyat, MD, PhD Liverpool Hope University

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Omid Alizadehkhaiyat, Dr, Liverpool Hope University
ClinicalTrials.gov Identifier: NCT02912130    
Other Study ID Numbers: LiverpoolHU
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Omid Alizadehkhaiyat, Liverpool Hope University:
Exercise
Nutrition
Sarcopenia
Healthy Ageing
Elderly
Muscular Hypertrophy
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Atrophy
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms