Clinical trial NCT02912130: Exercise and Nutrition Interventions in Age-related Sarcopenia
Official title: The Multidimensional Effects of Exercise and Nutritional Interventions on Musculoskeletal Functioning, Nutritional Status and Quality of Life in Age-related Sarcopenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Muscular Atrophy
Keywords: Exercise
Nutrition
Sarcopenia
Healthy Ageing
Elderly
Muscular Hypertrophy
Lead sponsor: Liverpool Hope University
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 160
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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).

Eligibility 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

Primary outcomes:
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
timeFrame: 16 weeks
Secondary outcomes:
measure: Grip Strength: Hand Grip Dynanometer (kg)
timeFrame: 16 weeks
measure: Gait speed during timed 4-meter walk (m/s)
timeFrame: 16 Weeks
measure: Time to complete five chair rises (m/s)
timeFrame: 16 Weeks
measure: Balance assessment: 1) feet side to side, 2) semi-tandem, 3) full tandem, and 4) single leg. Scored as Yes or No.
timeFrame: 16 Weeks
measure: Isometric Strength - Knee Flexion/Extension: Dynanometer (Nm/Kg)
timeFrame: 16 Weeks
measure: Muscle Fatigue: Upper & Lower limb: 25% of MVC during 60 seconds using Electromyography (EMG), measured in millivolts (mV)
timeFrame: 16 Weeks
measure: Exercise Tolerance: Six Minute Walk Test (metres)
timeFrame: 16 Weeks
measure: 10-metre Gait analysis during habitual walking speed using Electromyography (EMG)
timeFrame: 16 Weeks
measure: 10-metre Gait analysis during habitual walking speed using Three-Dimensional Motion Capture - 1) Spatiotemporal, 2) Kinematics
timeFrame: 16 Weeks
measure: Biochemical: Glycated Haemoglobin (HBA1c) (%)
timeFrame: 16 Weeks
measure: Biochemical: C-Reactive Protein (CRP) (mg/L)
timeFrame: 16 Weeks
measure: Biochemical: Insulin-Like Growth Factor 1 (IGF-1) (ng/ml)
timeFrame: 16 Weeks
measure: Arterial Pressure: Pulse Wave Velocity (m/s)
timeFrame: 16 Weeks
measure: Energy Balance: Periodic Food Diary (Kcal)
timeFrame: 16 Weeks
measure: World Health Organization Quality Of Life Assessment (WHOQOL): Each question is scored from 1-5 on a response scale
timeFrame: 16 Weeks
measure: Short-Form Health Survey (SF-12): Each question is scored between 1-6 on a response scale
timeFrame: 16 Weeks
measure: Activities of Daily Living (ADL): Each response is scored as either: 0 or 1
timeFrame: 16 Weeks
measure: Mini-Mental State Examination (MMSE): Each correct response is scored as 1 point
timeFrame: 16 Weeks
measure: Nutritional Status: Mini-Nutritional Assessment (MNA) - Classified as (Low, Moderate, High risk)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool Hope University
state: Merseyside
Study officials:
affiliation: Liverpool Hope University
name: Dr Omid Alizadehkhaiyat, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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