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Clinical Trials/NCT02912130
NCT02912130
Completed
Not Applicable

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

Liverpool Hope University1 site in 1 country110 target enrollmentSeptember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sarcopenia
Sponsor
Liverpool Hope University
Enrollment
110
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
7 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
September 1, 2016
End Date
December 1, 2023
Last Updated
7 months ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Omid Khaiyat, MD, PhD

Dr

Liverpool Hope University

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

Outcomes

Primary Outcomes

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

  • Grip Strength: Hand Grip Dynanometer (kg)(16 weeks)
  • Time to complete five chair rises (m/s)(16 Weeks)
  • Biochemical: Glycated Haemoglobin (HBA1c) (%)(16 Weeks)
  • Biochemical: Insulin-Like Growth Factor 1 (IGF-1) (ng/ml)(16 Weeks)
  • Exercise Tolerance: Six Minute Walk Test (metres)(16 Weeks)
  • Gait speed during timed 4-meter walk (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)
  • Biochemical: C-Reactive Protein (CRP) (mg/L)(16 Weeks)
  • Arterial Pressure: Pulse Wave Velocity (m/s)(16 Weeks)
  • World Health Organization Quality Of Life Assessment (WHOQOL): Each question is scored from 1-5 on a response scale(16 Weeks)
  • Muscle Fatigue: Upper & Lower limb: 25% of MVC during 60 seconds using Electromyography (EMG), measured in millivolts (mV)(16 Weeks)
  • Energy Balance: Periodic Food Diary (Kcal)(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)
  • 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)

Study Sites (1)

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