Contact information
Type
Scientific
Primary contact
Miss Emma-Louise Campbell
ORCID ID
Contact details
Institute for Biomedical Research into Human Movement and Health
Manchester Metropolitan University
Room T1.01
John Dalton Tower
Oxford Road
Manchester
M1 5GD
United Kingdom
+44 (0)161 2475950
e.campbell@mmu.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The role of pre-surgery training and protein supplementation in the mitigation of disuse muscle atrophy in patients undergoing elective hip arthroplasty.
Acronym
Study hypothesis
The normal loss of skeletal muscle mass and strength associated with old age (sarcopenia) poses a particular risk to the elderly when affected by illness or injury resulting in a period of immobilisation. Such situations, including immobilisation due to hip-fracture surgery, are common amongst the elderly population. The resulting disuse atrophy, particularly of the skeletal muscle of the lower limb, is a large contributing factor to the poor rehabilitation and high morbidity and mortality associated with incidences such as hip fracture. It has been shown that essential amino acid supplementation can stimulate muscle protein synthesis in both elderly individuals and young volunteers subject to conditions of chronic unloading. Furthermore, as skeletal muscle retains its capacity for adaptation into old age there is increasing evidence that older as well as younger individuals can limit and even reverse to a certain degree atrophy-associated muscle weakness by inducing neuromuscular and tendinous adaptations with resistance strength training programs.
At present, the limited previous research into the effects of chronic unloading in the elderly make it difficult to determine the extent with which reduction in muscle mass or decreased levels of physical activity are responsible for the characteristic loss of muscle strength associated with old age. Further research is necessary to examine the relationship between muscle function and chronic disuse to address this problem. It has been shown that knee and hip arthroplasty patients with better preoperative quality of life and physical function have less pain and better postoperative physical function than those with a lower level of preoperative physical activity. Combining preoperative strength training and essential amino acid (leucine) supplementation may increase muscle strength and function and as a result may mitigate the loss of muscle mass, hence increasing preoperative physiological reserve, potentially improving speed and extent of recovery of elderly patients following surgery.
Ethics approval
NHS Research Ethics Committee submission pending
Study design
Single-centre double-blind placebo controlled longitudinal study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Sarcopenia
Intervention
Interventions will consist of resistance training programs combined with essential amino acid (leucine) supplementation or non-essential amino acid (alanine) supplementation for 10 weeks, pre-surgery.
Participants in the training groups will be supplied with Thera-band® resistance exercise bands and instructed on how to perform resistance exercises aimed to build up and strengthen the knee extensor (quadriceps femoris) muscles. Participants will be asked to train three times weekly at home and will keep regular exercise diaries so exercise regimes can be monitored. Participants will also be contacted throughout the training period to ensure exercises are completed properly and to provide an opportunity for participants to ask any questions or resolve any issues they may have during the training. Participants will train for 10 weeks while awaiting surgery.
Participants will be asked to take daily oral suspensions containing either an essential amino acid, commercially available leucine (0.6g/kg body weight) (isolated from cows milk) or placebo, a non-essential amino acid alanine (same dosage). All participants will be asked to stop taking any nutritional supplementation at least one month before the study begins. Participants will be asked to take essential amino acid and placebo supplements once daily but not within 1 hour before or after resistance training during the training period.
The total duration of follow-up will be 3 months post surgery.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Muscle thickness and architecture, measured by ultrasound
2. Muscle strength, measured by dynamometer
These outcomes will be assessed at baseline (10 weeks prior to surgery), immediately prior to surgery, and at 1 and 3 months post surgery.
Secondary outcome measures
None
Overall trial start date
01/01/2011
Overall trial end date
31/12/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Elderly patients (60+ years), males and females, awaiting elective total hip arthroplasty but otherwise in relatively good health
2. Participants must have a good understanding of English to understand verbal explanations and written information given in English
3. Participants must be able to give fully informed consent
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
45
Participant exclusion criteria
All participants will be screened by a physician and will be excluded from the study if they suffer from or have ever suffered from:
1. Previous stroke
2. Uncontrolled cardiovascular disease
3. Motor neurone disease
4. Parkinson's disease
5. Medically diagnosed osteoporosis
6. Type II diabetes
7. Hypertension or myocardial infarction within the previous 2 years
8. Acute febrile or systemic disease within the past 2 years
9. Currently taking beta blockers
Recruitment start date
01/01/2011
Recruitment end date
31/12/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute for Biomedical Research into Human Movement and Health
Manchester
M1 5GD
United Kingdom
Sponsor information
Organisation
Barts and the London School of Medicine (UK)
Sponsor details
c/o Mrs Gayle Maffulli
Centre for Sports and Exercise Medicine
Barts and the London School of Medicine
Mile End Hospital
Bancroft Road
London
E1 4DG
United Kingdom
+44 (0)20 82238839
g.maffulli@qmul.ac.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research council
Funder name
EU Seventh Framework Programme (FP7) (Europe)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Institut National de la Sante et de la Recherge Medicale (INSERM) (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary