Exercise and Nutrition Interventions in Age-related Sarcopenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Sarcopenia, Muscular Atrophy

Intervention / Treatment
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* Dietary Supplement: Protein Supplementation
* Other: Aerobic Exercise
* Other: Resistance Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No Intervention | |
| Experimental: Exercise<br>Aerobic Exercise i.e. 30-60 minutes per week of moderate intensity exercise Resistance Exercise i.e. 60 minutes per week of progressive resistance training | Other: Aerobic Exercise<br>* 30-60 minutes per week of moderate intensity exercise<br>Other: Resistance Exercise<br>* 60 minutes per week of progressive resistance training<br>|
| Experimental: Exercise+Nutrition<br>Aerobic Exercise i.e. 30-60 minutes per week of moderate intensity exercise Dietary Supplement i.e. Protein Supplementation 1.2-1.5g/kg/body weight per day | Dietary Supplement: Protein Supplementation<br>* 1.2-1.5g/kg/body weight per day<br>Other: Aerobic Exercise<br>* 30-60 minutes per week of moderate intensity exercise<br>Other: Resistance Exercise<br>* 60 minutes per week of progressive resistance training<br>|
| Experimental: Nutrition<br>Dietary Supplement: Protein Supplementation i.e. 1.2-1.5g/kg/body weight per day | Dietary Supplement: Protein Supplementation<br>* 1.2-1.5g/kg/body weight per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Muscle Fatigue: Upper & Lower limb: 25% of MVC during 60 seconds using Electromyography (EMG), measured in millivolts (mV) |  | 16 Weeks | 
| Exercise Tolerance: Six Minute Walk Test (metres) |  | 16 Weeks | 
| 10-metre Gait analysis during habitual walking speed using Electromyography (EMG) |  | 16 Weeks | 
| 10-metre Gait analysis during habitual walking speed using Three-Dimensional Motion Capture - 1) Spatiotemporal, 2) Kinematics |  | 16 Weeks | 
| Biochemical: Glycated Haemoglobin (HBA1c) (%) |  | 16 Weeks | 
| Biochemical: C-Reactive Protein (CRP) (mg/L) |  | 16 Weeks | 
| Biochemical: Insulin-Like Growth Factor 1 (IGF-1) (ng/ml) |  | 16 Weeks | 
| Arterial Pressure: Pulse Wave Velocity (m/s) |  | 16 Weeks | 
| Energy Balance: Periodic Food Diary (Kcal) |  | 16 Weeks | 
| World Health Organization Quality Of Life Assessment (WHOQOL): Each question is scored from 1-5 on a response scale |  | 16 Weeks | 
| Short-Form Health Survey (SF-12): Each question is scored between 1-6 on a response scale |  | 16 Weeks | 
| Activities of Daily Living (ADL): Each response is scored as either: 0 or 1 |  | 16 Weeks | 
| Mini-Mental State Examination (MMSE): Each correct response is scored as 1 point |  | 16 Weeks | 
| Nutritional Status: Mini-Nutritional Assessment (MNA) - Classified as (Low, Moderate, High risk) |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Nutrition, Sarcopenia, Healthy Ageing, Elderly, Muscular Hypertrophy