Condition category
Musculoskeletal Diseases
Date applied
15/02/2010
Date assigned
17/03/2010
Last edited
05/08/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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

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

Publication citations

Additional files

Editorial Notes