- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01547988
Training Improves Balance Control
Improving Balance Control and Self-Reported Lower Extremity Function in Community Dwelling Older Adults - A Randomized Control Study
The purpose of this study was to evaluate the effect of a group-based functional and specific balance training program on balance function in healthy older adults. It is commonly considered difficult to improve balance function in healthy older adults. The program included dual-task exercises; physical training exercises and a cognitive task (e.g. reading or reciting a story) performed simultaneously, as well as perturbation exercises, where balance is challenged in unexpected ways.
The investigators hypothesized that following the proposed training, older adults would improve their speed of taking a step in both single and dual task conditions, refine their ability to control balance when standing still and improve their self-reported physical function.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- NeuroMuscular Research Center, Boston University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- 65 years or older
- Independently ambulatory (cane acceptable; not walker)
- Score better than 45 on the Berg Balance Scale
- Higher than 24 Mini-Mental Score
Exclusion Criteria:
- Severe focal muscle weakness or visual impairment
- Known neurological disorders (including stroke, Parkinson disease)
- Metastatic cancer
- Use of medication that impairs balance or strength
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Balance Training Intervention
The Balance Training Intervention group received 24 training sessions over three months that included perturbation as well as dual-task exercises.
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The intervention group participated in a total of 24 one-hour training sessions over a period of 12 weeks.
The training program utilized different size balls as a general tool in a series of progressively more difficult exercises targeting sitting, standing, and gait-related balance control.
The program included exercises at five different levels of progressively more challenging balance exercises.
Levels 1-4 focused on voluntarily controlled balance exercises, whereas level 5 also included perturbation exercises to trigger automatic compensatory stepping responses.
All levels included attention-demanding dual task exercises that required subjects to simultaneously perform motor and cognitive activities.
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Ingen inngripen: Reference Group
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The intervention group participated in a total of 24 one-hour training sessions over a period of 12 weeks.
The training program utilized different size balls as a general tool in a series of progressively more difficult exercises targeting sitting, standing, and gait-related balance control.
The program included exercises at five different levels of progressively more challenging balance exercises.
Levels 1-4 focused on voluntarily controlled balance exercises, whereas level 5 also included perturbation exercises to trigger automatic compensatory stepping responses.
All levels included attention-demanding dual task exercises that required subjects to simultaneously perform motor and cognitive activities.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Reaction time of dual task step execution
Tidsramme: 12 weeks
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Subjects stand on a force platform and are asked to execute a step as rapidly as possible following a tactile stimulus on their heel while performing a cognitive attention demanding task (Stroop task - call out colors of words that are names of colors, e.g. the word "BLUE" is presented in yellow letters).
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12 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Late Life Functional Disability Index - LLFDI
Tidsramme: 12 weeks
|
Self-reported measure of function
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12 weeks
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Lars IE Oddsson, PhD, NeuroMuscular Research Center, Boston University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Lars I. E. Oddsson, Patrick Boissy and Itshak Melzer. How to improve gait and balance function in elderly individuals-compliance with principles of training. European Review of Aging and Physical Activity Volume 4, Number 1, 15-23, DOI: 10.1007/s11556-007-0019-9
- Melzer I, Oddsson LI. The effect of a cognitive task on voluntary step execution in healthy elderly and young individuals. J Am Geriatr Soc. 2004 Aug;52(8):1255-62. doi: 10.1111/j.1532-5415.2004.52353.x.
- Melzer I, Shtilman I, Rosenblatt N, Oddsson LI. Reliability of voluntary step execution behavior under single and dual task conditions. J Neuroeng Rehabil. 2007 May 29;4:16. doi: 10.1186/1743-0003-4-16.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Antatt)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- RRF 2001-056
Legemiddel- og utstyrsinformasjon, studiedokumenter
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