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Designing clinical trials of interventions for mobility disability: results from the lifestyle interventions and independence for elders pilot (LIFE-P) trial.
| Content Provider | Semantic Scholar |
|---|---|
| Author | Espeland, Mark A. Gill, Thomas M. Guralnik, Jack M. Miller, Michael E. Fielding, Roger A. Newman, Anne B. Pahor, Marco |
| Copyright Year | 2007 |
| Abstract | BACKGROUND Clinical trials to assess interventions for mobility disability are critically needed; however, data for efficiently designing such trials are lacking. METHODS Results are described from a pilot clinical trial in which 424 volunteers aged 70-89 years were randomly assigned to one of two interventions-physical activity or a healthy aging education program-and followed for a planned minimum of 12 months. We evaluated the longitudinal distributions of four standardized outcomes to contrast how they may serve as primary outcomes of future clinical trials: ability to walk 400 meters, ability to walk 4 meters in < or =10 seconds, a physical performance battery, and a questionnaire focused on physical function. RESULTS Changes in all four outcomes were interrelated over time. The ability to walk 400 meters as a dichotomous outcome provided the smallest sample size projections (i.e., appeared to be the most efficient outcome). It loaded most heavily on the underlying latent variable in structural equation modeling with a weight of 80%. A 4-year trial based on the outcome of the 400-meter walk is projected to require N = 962-2234 to detect an intervention effect of 30%-20% with 90% power. CONCLUSIONS Future clinical trials of interventions designed to influence mobility disability may have greater efficiency if they adopt the ability to complete a 400-meter walk as their primary outcome. |
| File Format | PDF HTM / HTML |
| DOI | 10.1093/gerona/62.11.1237 |
| Alternate Webpage(s) | https://www.thelifestudy.org/docs/AP04-005_Espeland_Published.pdf |
| Alternate Webpage(s) | https://watermark.silverchair.com/1237.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAAb8wggG7BgkqhkiG9w0BBwagggGsMIIBqAIBADCCAaEGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMrfHg0KLe3gKpkX7XAgEQgIIBcqX1QCEMODq5BSyzLZfCgRvNr_iyQ1kY81YxwjqMbeukJJvASlU-VIe6Mvcu9euPIb_fdotQ9eUEpSsEj_OL-MRX0zn_fnISvL_ka0pWtqDbMoMFiL98qnuhEWHjBx9AcRVgF9hIGuZX251zsMe-IrQ4tzx-yWfo09WIu03-Lgu7iPv_EVH_d2yPEm03fj5RbZxfyVzTtGGnne0b7bDq64KpG215j6r6kS_roaPTOU9Mhas2L7i09ZW5nK-fh2jaBPebFx5zaCB8ouzfBNQt8b1JQCEOZeqV1gcs_MSBcq_CB0pJSCjd4TYKCaODZkU9XuictWu6AUeFDx6tdYKTtGqd-SMJ0YjeSPNs4EicKE7qTStwr-VUCXXPELT3Li8ynugwBnimgZAmyziJ6uPlOn1IAoQTTn7pEQgNS-oDXqNOpo-sCIhpzDVoiHK2F6V9CikhGKIF_BtrNohnYi0lUzLdLthcKRYM49lBZH2k1hvEnOc |
| PubMed reference number | 18000143 |
| Alternate Webpage(s) | https://doi.org/10.1093/gerona%2F62.11.1237 |
| Journal | Medline |
| Volume Number | 62 |
| Issue Number | 11 |
| Journal | The journals of gerontology. Series A, Biological sciences and medical sciences |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
