Exercise and Nutrition Interventions in Age-related Sarcopenia

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02912130
• Other study ID #: LiverpoolHU
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 2020

Study information

• Verified date: September 2020
• Source: Liverpool Hope University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Muscular Atrophy
• Sarcopenia

Intervention

Dietary Supplement:
• Protein Supplementation
1.2-1.5g/kg/body weight per day

Other:
• Aerobic Exercise
30-60 minutes per week of moderate intensity exercise
• Resistance Exercise
60 minutes per week of progressive resistance training

Locations

Country	Name	City	State
United Kingdom	Liverpool Hope University	Liverpool	Merseyside

Sponsors (1)

Lead Sponsor	Collaborator
Liverpool Hope University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (12)

Chang SF, Lin PL. Systematic Literature Review and Meta-Analysis of the Association of Sarcopenia With Mortality. Worldviews Evid Based Nurs. 2016 Apr;13(2):153-62. doi: 10.1111/wvn.12147. Epub 2016 Feb 4. Review. — View Citation

Churchward-Venne TA, Holwerda AM, Phillips SM, van Loon LJ. What is the Optimal Amount of Protein to Support Post-Exercise Skeletal Muscle Reconditioning in the Older Adult? Sports Med. 2016 Sep;46(9):1205-12. doi: 10.1007/s40279-016-0504-2. Review. — View Citation

Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinková E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13. — View Citation

Csapo R, Alegre LM. Effects of resistance training with moderate vs heavy loads on muscle mass and strength in the elderly: A meta-analysis. Scand J Med Sci Sports. 2016 Sep;26(9):995-1006. doi: 10.1111/sms.12536. Epub 2015 Aug 24. Review. — View Citation

Ko SU, Hausdorff JM, Ferrucci L. Age-associated differences in the gait pattern changes of older adults during fast-speed and fatigue conditions: results from the Baltimore longitudinal study of ageing. Age Ageing. 2010 Nov;39(6):688-94. doi: 10.1093/ageing/afq113. Epub 2010 Sep 10. — View Citation

Komar B, Schwingshackl L, Hoffmann G. Effects of leucine-rich protein supplements on anthropometric parameter and muscle strength in the elderly: a systematic review and meta-analysis. J Nutr Health Aging. 2015 Apr;19(4):437-46. doi: 10.1007/s12603-014-0559-4. Review. — View Citation

Kraschnewski JL, Sciamanna CN, Poger JM, Rovniak LS, Lehman EB, Cooper AB, Ballentine NH, Ciccolo JT. Is strength training associated with mortality benefits? A 15year cohort study of US older adults. Prev Med. 2016 Jun;87:121-127. doi: 10.1016/j.ypmed.2016.02.038. Epub 2016 Feb 24. — View Citation

Lourenço RA, Pérez-Zepeda M, Gutiérrez-Robledo L, García-García FJ, Rodríguez Mañas L. Performance of the European Working Group on Sarcopenia in Older People algorithm in screening older adults for muscle mass assessment. Age Ageing. 2015 Mar;44(2):334-8. doi: 10.1093/ageing/afu192. Epub 2014 Dec 23. — View Citation

Witard OC, McGlory C, Hamilton DL, Phillips SM. Growing older with health and vitality: a nexus of physical activity, exercise and nutrition. Biogerontology. 2016 Jun;17(3):529-46. doi: 10.1007/s10522-016-9637-9. Epub 2016 Feb 15. Review. — View Citation

Witard OC, Wardle SL, Macnaughton LS, Hodgson AB, Tipton KD. Protein Considerations for Optimising Skeletal Muscle Mass in Healthy Young and Older Adults. Nutrients. 2016 Mar 23;8(4):181. doi: 10.3390/nu8040181. Review. — View Citation

Xu ZR, Tan ZJ, Zhang Q, Gui QF, Yang YM. Clinical effectiveness of protein and amino acid supplementation on building muscle mass in elderly people: a meta-analysis. PLoS One. 2014 Sep 30;9(9):e109141. doi: 10.1371/journal.pone.0109141. eCollection 2014. — View Citation

Yu SC, Khow KS, Jadczak AD, Visvanathan R. Clinical Screening Tools for Sarcopenia and Its Management. Curr Gerontol Geriatr Res. 2016;2016:5978523. doi: 10.1155/2016/5978523. Epub 2016 Feb 4. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

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

External Links

•   Recruitment Links: Social Media