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Exercise and Nutrition Interventions in Age-related Sarcopenia

Primary Purpose

Sarcopenia, Muscular Atrophy

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Protein Supplementation
Aerobic Exercise
Resistance Exercise
Sponsored by
Liverpool Hope University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring Exercise, Nutrition, Sarcopenia, Healthy Ageing, Elderly, Muscular Hypertrophy

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Liverpool Hope University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

Exercise

Exercise+Nutrition

Nutrition

Arm Description

No Intervention

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

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 i.e. 1.2-1.5g/kg/body weight per day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2016
Last Updated
September 1, 2020
Sponsor
Liverpool Hope University
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1. Study Identification

Unique Protocol Identification Number
NCT02912130
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liverpool Hope University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Muscular Atrophy
Keywords
Exercise, Nutrition, Sarcopenia, Healthy Ageing, Elderly, Muscular Hypertrophy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No Intervention
Arm Title
Exercise
Arm Type
Experimental
Arm Description
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
Arm Title
Exercise+Nutrition
Arm Type
Experimental
Arm Description
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
Arm Title
Nutrition
Arm Type
Experimental
Arm Description
Dietary Supplement: Protein Supplementation i.e. 1.2-1.5g/kg/body weight per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein Supplementation
Intervention Description
1.2-1.5g/kg/body weight per day
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise
Intervention Description
30-60 minutes per week of moderate intensity exercise
Intervention Type
Other
Intervention Name(s)
Resistance Exercise
Intervention Description
60 minutes per week of progressive resistance training
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Grip Strength: Hand Grip Dynanometer (kg)
Time Frame
16 weeks
Title
Gait speed during timed 4-meter walk (m/s)
Time Frame
16 Weeks
Title
Time to complete five chair rises (m/s)
Time Frame
16 Weeks
Title
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
Title
Isometric Strength - Knee Flexion/Extension: Dynanometer (Nm/Kg)
Time Frame
16 Weeks
Title
Muscle Fatigue: Upper & Lower limb: 25% of MVC during 60 seconds using Electromyography (EMG), measured in millivolts (mV)
Time Frame
16 Weeks
Title
Exercise Tolerance: Six Minute Walk Test (metres)
Time Frame
16 Weeks
Title
10-metre Gait analysis during habitual walking speed using Electromyography (EMG)
Time Frame
16 Weeks
Title
10-metre Gait analysis during habitual walking speed using Three-Dimensional Motion Capture - 1) Spatiotemporal, 2) Kinematics
Time Frame
16 Weeks
Title
Biochemical: Glycated Haemoglobin (HBA1c) (%)
Time Frame
16 Weeks
Title
Biochemical: C-Reactive Protein (CRP) (mg/L)
Time Frame
16 Weeks
Title
Biochemical: Insulin-Like Growth Factor 1 (IGF-1) (ng/ml)
Time Frame
16 Weeks
Title
Arterial Pressure: Pulse Wave Velocity (m/s)
Time Frame
16 Weeks
Title
Energy Balance: Periodic Food Diary (Kcal)
Time Frame
16 Weeks
Title
World Health Organization Quality Of Life Assessment (WHOQOL): Each question is scored from 1-5 on a response scale
Time Frame
16 Weeks
Title
Short-Form Health Survey (SF-12): Each question is scored between 1-6 on a response scale
Time Frame
16 Weeks
Title
Activities of Daily Living (ADL): Each response is scored as either: 0 or 1
Time Frame
16 Weeks
Title
Mini-Mental State Examination (MMSE): Each correct response is scored as 1 point
Time Frame
16 Weeks
Title
Nutritional Status: Mini-Nutritional Assessment (MNA) - Classified as (Low, Moderate, High risk)
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Omid Alizadehkhaiyat, MD, PhD
Organizational Affiliation
Liverpool Hope University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liverpool Hope University
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L16 9JD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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20392703
Citation
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Links:
URL
https://twitter.com/StudyAgeing
Description
Recruitment Links: Social Media

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Exercise and Nutrition Interventions in Age-related Sarcopenia

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