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Exercise for falls prevention in lower limb amputees

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN30210699
Enrollment
48
Registered
2015-07-27
Start date
2015-05-18
Completion date
Unknown
Last updated
2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Current interventions as of 23/11/2020: The intervention will be a personalised exercise programme consisting of group-based (supervised, circuit-training style) and home-based physica
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 a

Sponsors

University of Hull
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Contacts

Public ContactNatalie Vanicek
n.vanicek@hull.ac.uk+44 (0)1482 463607

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026