Amputation 

Recruitment status:

Recruiting

Primary Sponsor:

University of Hull

Recruitment countries:

United Kingdom

Health condition studied:

Individuals with lower limb amputation due to vascular or traumatic reasons and wearing a prosthetic limb.
Musculoskeletal Diseases
Limb amputation

URL:

Link to the clinical trial website

About the trial

Interventions:

The intervention will be a supported exercise programme consisting of group-based (supervised, circuit-training style) and home-based physical activities lasting 12 weeks. The exercises will consist of walking-based activities, functional strength tasks, flexibility and balance; should be performed 3 times a week, progressing to 4 times a week ; and starting from 30 minutes and progressing to 1 hour. Thus, the exercises will be evidence-based, graded (becoming progressively more difficult) and designed specifically for below- and above-knee amputees.

The control group will not alter their levels of daily activity and will not engage in a supported exercise programme/intervention.

Key inclusion and exclusion criteria:

• Inclusion criteria: Inclusion criteria have been considered to include all community-dwelling, lower limb amputees patients aged 18-85 years, both males and females, who have had a unilateral below-knee or above-knee amputation for reasons related to either dysvascularity (e.g., diabetes mellitus), trauma, infection, neurological disorder (e.g., diabetic neuropathy) or neoplasia (e.g. benign or malignant growth). Participants who have had one or more falls within the last 2 years will be included in the study. Prospective participants must wear their prosthesis on a daily basis and have completed a gait retraining or rehabilitation programme at some time.
• Exclusion criteria: 1. The presence of ‘non-lifestyle’ chronic disease (e.g., multiple sclerosis, Parkinson’s disease, genetic disorders, neurological disorders other than cause of amputation (e.g., diabetic neuropathy, acquired brain injury, autoimmune disorders)
  2. Have any cardiac complications, such as a previous heart attack, angina, or have had a coronary artery bypass
  3. Severe infections and fever
  4. Uncontrolled asthma
  5. Uncontrolled diabetes
  6. Systolic blood pressure of more than 180 mmHg or diastolic blood pressure of more than 105 mmHg (as measured upon entry into the study)
  7. Currently on hypertensive medication AND with a systolic blood pressure of more than 160 mmHg or a diastolic pressure greater than 90 mmHg (as measured upon entry into the study)
  8. Recent cerebrovascular accident or stroke
  9. Pregnancy
  10. Severe osteoporosis
  11. Presence of diseases severely affecting memory (e.g. dementia)
  12. Presence of current life-limiting illness (e.g. cancer)
  13. Current musculoskeletal injury in the lower limbs, including severe lower back pain
  14. The inability to give informed consent
  15. Unwillingness to allow their GP to be informed of their participation in the study
  16. Participants unable to understand English will be excluded, as all instructions will be given in English only
  17. Participants currently involved in a falls prevention or structured exercise programme will also be excluded
  

• Age minimum: 
• Age maximum: 
• Gender:  Both

Primary outcomes:

Falls history over a 12 month period and musculoskeletal parameters (e.g., walking speed and gait function, muscle strength and balance profiles).

Secondary outcomes:

Quality of life, fear of falling and general well-being parameters.

Target sample size:

48

Study type:

Observational

Study design:

Single centre case control trial (Prevention)

Contacts:

• Name: Natalie Vanicek
• Address:  University of Hull Department of Sport Health and Exercise Science Cottingham Rd
• Phone:  +44 (0)1482 463607
• Email:  n.vanicek@hull.ac.uk
• Affiliation: 

Technical details

Scientific title:

Exercise training to maximise musculoskeletal function for falls prevention in lower limb amputees

Sources of monetary support:

British Association of Chartered Physiotherapists in Amputee Rehabilitation, Help for Health Trust

Secondary sponsors:

Main ID:

ISRCTN30210699

Secondary ID:

N/A

Register:

ISRCTN

Date of registration:

27/07/2015

Date of first enrollment:

18/05/2015

Last refreshed:

17 October 2016