Role of exercise and diet in disuse atrophy in hip surgery patients

ISRCTN	ISRCTN32820033
DOI	https://doi.org/10.1186/ISRCTN32820033
Secondary identifying numbers	N/A

Submission date: 15/02/2010
Registration date: 17/03/2010
Last edited: 12/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Emma-Louise Campbell
Scientific

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

Phone	+44 (0)161 2475950
Email	e.campbell@mmu.ac.uk

Study information

Study design	Single-centre double-blind placebo controlled longitudinal study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	The role of pre-surgery training and protein supplementation in the mitigation of disuse muscle atrophy in patients undergoing elective hip arthroplasty.
Study objectives	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(s)	NHS Research Ethics Committee submission pending
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2011
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	45
Key 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
Key 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
Date of first enrolment	01/01/2011
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Institute for Biomedical Research into Human Movement and Health

Manchester
M1 5GD
United Kingdom

Sponsor information

Barts and the London School of Medicine (UK)
Hospital/treatment centre

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
England
United Kingdom

Phone	+44 (0)20 82238839
Email	g.maffulli@qmul.ac.uk
"ROR"	https://ror.org/00b31g692

Funders

Funder type

Research council

EU Seventh Framework Programme (FP7) (Europe)

No information available

Institut National de la Sante et de la Recherge Medicale (INSERM) (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

12/04/2017: No publications found in PubMed, verifying study status with principal investigator.