Allopurinol in Functional Impairment (ALFIE) trial: improving muscle strength

Not Applicable

Completed

• Conditions: Primary Sarcopenia; Musculoskeletal Diseases; Muscle wasting and atrophy, not elsewhere classified

• Registration Number: ISRCTN03331094
• Lead Sponsor: niversity of Dundee (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-17
• Study Completion: 2018-02-28
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Current inclusion criteria as of 11/11/2014:
1. Age 65 years and over
2. 6-Minute Walk Distance <400 m

Previous inclusion criteria:
1. Age 65 and over
2. Muscle strength (grip strength <20kg women;<30kg men) AND physical performance (Short Physical Performance Battery test score less than or equal to 8/12). This will ensure both that the study population have sarcopenia according to European consensus guidelines
3. Gait speed less than 0.8m/s

Exclusion Criteria

Current exclusion criteria as of 11/11/2014:
1. Documented history of peripheral arterial disease
2. Pre-existing diagnosis of severe heart failure (LVEF <35%)
3. Malignancy under active treatment (excluding basal cell carcinoma)
4. Severe COPD (physician diagnosis)
5. Intolerance to allopurinol
6. Individuals with Active Acute Gout currently taking allopurinol; or those who have stopped taking allopurinol =1 month previously for this condition.
7. On long-term high-dose steroids (eq. Prednisolone >10 mg/day due to risk of steroid-induced myopathy and osteoporosis)
8. Immobility that would render the patient incapable of doing the Short Physical Performance Battery Test (SPPB) or 6MWT
9. Patients who have participated in any other clinical drug trial within the previous 30 days will be excluded
10. Cognitive impairment precluding informed consent
11. Any other considered by a study physician to be inappropriate for inclusion

Previous exclusion criteria:
1. Previously enrolled into the study
2. Pre-existing diagnosis of heart failure or any malignancy (excluding basal cell carcinoma)
3. Documented intolerance to allopurinol
4. Immobility that would render the patient incapable of doing the Short performance Battery Test (SPBT)

Study & Design

• Study Type: Interventional
• Study Design: Not specified