Exercise and Nutrition Interventions in Age-related Sarcopenia

September 1, 2020 updated by: Omid Alizadehkhaiyat, Liverpool Hope University

The Multidimensional Effects of Exercise and Nutritional Interventions on Musculoskeletal Functioning, Nutritional Status and Quality of Life 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L16 9JD
        • Liverpool Hope University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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
Other: Aerobic Exercise
30-60 minutes per week of moderate intensity exercise
Other: Resistance Exercise
60 minutes per week of progressive resistance training
Dietary supplement: Protein Supplementation
1.2-1.5g/kg/body weight per day
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Grip Strength: Hand Grip Dynanometer (kg)
Time Frame: 16 weeks
16 weeks
Gait speed during timed 4-meter walk (m/s)
Time Frame: 16 Weeks
16 Weeks
Time to complete five chair rises (m/s)
Time Frame: 16 Weeks
16 Weeks
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
16 Weeks
Isometric Strength - Knee Flexion/Extension: Dynanometer (Nm/Kg)
Time Frame: 16 Weeks
16 Weeks
Muscle Fatigue: Upper & Lower limb: 25% of MVC during 60 seconds using Electromyography (EMG), measured in millivolts (mV)
Time Frame: 16 Weeks
16 Weeks
Exercise Tolerance: Six Minute Walk Test (metres)
Time Frame: 16 Weeks
16 Weeks
10-metre Gait analysis during habitual walking speed using Electromyography (EMG)
Time Frame: 16 Weeks
16 Weeks
10-metre Gait analysis during habitual walking speed using Three-Dimensional Motion Capture - 1) Spatiotemporal, 2) Kinematics
Time Frame: 16 Weeks
16 Weeks
Biochemical: Glycated Haemoglobin (HBA1c) (%)
Time Frame: 16 Weeks
16 Weeks
Biochemical: C-Reactive Protein (CRP) (mg/L)
Time Frame: 16 Weeks
16 Weeks
Biochemical: Insulin-Like Growth Factor 1 (IGF-1) (ng/ml)
Time Frame: 16 Weeks
16 Weeks
Arterial Pressure: Pulse Wave Velocity (m/s)
Time Frame: 16 Weeks
16 Weeks
Energy Balance: Periodic Food Diary (Kcal)
Time Frame: 16 Weeks
16 Weeks
World Health Organization Quality Of Life Assessment (WHOQOL): Each question is scored from 1-5 on a response scale
Time Frame: 16 Weeks
16 Weeks
Short-Form Health Survey (SF-12): Each question is scored between 1-6 on a response scale
Time Frame: 16 Weeks
16 Weeks
Activities of Daily Living (ADL): Each response is scored as either: 0 or 1
Time Frame: 16 Weeks
16 Weeks
Mini-Mental State Examination (MMSE): Each correct response is scored as 1 point
Time Frame: 16 Weeks
16 Weeks
Nutritional Status: Mini-Nutritional Assessment (MNA) - Classified as (Low, Moderate, High risk)
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liverpool Hope University

Investigators

  • Principal Investigator: Dr Omid Alizadehkhaiyat, MD, PhD, Liverpool Hope University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (Estimate)

September 23, 2016

Study Record Updates

Last Update Posted (Actual)

September 3, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LiverpoolHU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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