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
Verified date | September 2020 |
Source | Liverpool Hope University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Liverpool Hope University | Liverpool | Merseyside |
Lead Sponsor | Collaborator |
---|---|
Liverpool Hope University |
United Kingdom,
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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
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 |
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