- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04767932
Investigation of Impacts of Vibration on Muscular Strength and Functional Performance of Upper Limbs of Older Adults
22. februar 2021 oppdatert av: Taipei Medical University
The elderly population is increasing at worldwide.
The need of health promotion and maintenance for elderly adults has become a critical issue.
According to a national investigation in 2017, the number of people over 65 years old accounts for 13.33% of the total population and would reach 20.1% by 2050.
Muscle strength and functional performances of upper limbs play an important role in most daily activities in elderly adults.
However, with aging, the muscle strength of upper extremities could be affected and decrease the functional performances of daily living.
Vibration exercise can be used to induce the muscle contraction and motor control in lower limbs for people with neuromuscular disorders.
Few studies have investigated the training effects on muscle strength and functional performances of upper limbs for elderly adults。Therefore, appropriate training devices and exercise programs to facilitate the muscle strength and functional performances of upper limbs in elderly people would be needed for clinical therapists.
Therefore, the purpose of this study was to develop a vibration training device and investigate the training effects on muscle strength and functional performances of upper limbs in elderly people.
This study will recruit 44 elderly adults, evaluating the muscle strength and functional performances of upper limbs before and after interventions.
All subjects will be randomized assign to experimental and control groups; the experimental group will perform 30mins/ section, three times weekly for 8 weeks vibration training, and the control group will receive regular exercise training at same time.
Two-way ANOVA with repeated measure will be applied to analyze the training effects and difference in the muscle strength and functional performances of upper limbs between two groups.
SPSS version 18.0 statistical software will be used.
The α level for statistical significance is set at 0.05.
Studieoversikt
Detaljert beskrivelse
Vibration exercise can be used to induce the muscle contraction and motor control in lower limbs for people with neuromuscular disorders.
Few studies have investigated the training effects on muscle strength and functional performances of upper limbs for elderly adults。Therefore, appropriate training devices and exercise programs to facilitate the muscle strength and functional performances of upper limbs in elderly people would be needed for clinical therapists.
Therefore, the purpose of this study was to develop a vibration training device and investigate the training effects on muscle strength and functional performances of upper limbs in elderly people.
This study will recruit 44 elderly adults, evaluating the muscle strength and functional performances of upper limbs before and after interventions.
All subjects will be randomized assign to experimental and control groups; the experimental group will perform 30mins/ section, three times weekly for 8 weeks vibration training, and the control group will receive regular exercise training at same time.
Two-way ANOVA with repeated measure will be applied to analyze the training effects and difference in the muscle strength and functional performances of upper limbs between two groups.
SPSS version 18.0 statistical software will be used.
The α level for statistical significance is set at 0.05.
Studietype
Intervensjonell
Registrering (Forventet)
44
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
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Taipei city, Taiwan, 110301
- TMU
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
65 år til 85 år (Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
Sarcopenia of older people
Exclusion Criteria:
- Upper limbs acute or chronic nerve, musculoskeletal injury within 6 months
- Upper extremity surgery in 6 months
- without a pacemaker
- without severe vision or hearing problems
- without severe heart disease
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: control group
the control group will receive regular exercise training at same time.
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Experimental: vibration intervention the experimental group will perform 20mins/ section, three times weekly for 8 weeks vibration training
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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muscle strength of upper limbs.
Tidsramme: 15 min
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use MicroFET3 to understand physical fitness of upper limbs between groups after intervention .The tool for assessing upper limb muscle strength is a tool with good reliability and validity.
It includes wrist flexor, extensor, brachioradialis, biceps, triceps, and deltoid muscle strength performance.
The researcher places the muscle to be measured and asks the subject to hold the dynamometer for three to five seconds, measure twice, record in kilograms to one decimal place, and measure twice in total.
The higher value is recorded in kilograms to the next decimal place.
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15 min
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Assess the improvement of quality of life due to muscle strength improvement
Tidsramme: 20 min
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IADL+ Quality of life to understand physical fitness and functional performance of upper limbs between groups after intervention .This sub-questionnaire is based on the subjective feelings of the elderly in the last two weeks, measured by interviews and observation behaviors.
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20 min
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: chia-hui kao, master, Student
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
26. oktober 2020
Primær fullføring (Faktiske)
31. januar 2021
Studiet fullført (Forventet)
28. april 2021
Datoer for studieregistrering
Først innsendt
12. november 2020
Først innsendt som oppfylte QC-kriteriene
22. februar 2021
Først lagt ut (Faktiske)
23. februar 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. februar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. februar 2021
Sist bekreftet
1. oktober 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- N201907023
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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