Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Miss Emma-Louise Campbell


Contact details

Institute for Biomedical Research into Human Movement and Health
Manchester Metropolitan University
Room T1.01
John Dalton Tower
Oxford Road
M1 5GD
United Kingdom
+44 (0)161 2475950

Additional identifiers

EudraCT number number

Protocol/serial number


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.


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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet




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 cow’s 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



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


Overall trial start date


Overall trial end date


Reason abandoned


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Institute for Biomedical Research into Human Movement and Health
M1 5GD
United Kingdom

Sponsor information


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
E1 4DG
United Kingdom
+44 (0)20 82238839

Sponsor type

Hospital/treatment centre



Funder type

Research council

Funder name

EU Seventh Framework Programme (FP7) (Europe)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

Additional files

Editorial Notes