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A Randomised Controlled Trial of Home-based Exercise Intervention for Caregivers of Persons With Dementia

5. mai 2016 oppdatert av: Dr. Chan Wai Chi, The University of Hong Kong
The study aims to compare the efficacy of a home-based structured exercise programme (12-step sitting Tai Chi) involving both persons with dementia and their caregivers with a standard non-exercise social contact control in treating depression among caregivers. The effects of exercise on their cognition, quality of life and balance ability are also assessed. We will also examine if BDNF polymorphisms modulate mood changes in response to exercise intervention. Focus groups will be organised at the end to find out the facilitators and barriers in taking up exercise. The findings may offer an avenue of intervention by providing a low cost, relatively safe and effective treatment for dementia caregivers, which may in turn benefit the persons with dementia.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The proposed study is a single-blind randomised controlled trial for two years. We will compare the efficacy of a home-based structured exercise programme (12-step sitting Tai Chi) for both carers and care recipients with a standard non-exercise social contact control in the treatment of depression among caregivers of persons with dementia. The study hypotheses include:

  1. The structured home-based exercise programme will reduce caregiver depression. (Primary outcome)
  2. The home-based exercise will improve caregivers' cognitive performance, quality of life and balance ability at the end of the study. (Secondary outcome)
  3. The home-based exercise will improve the cognitive performance, quality of life and balance ability of persons with dementia at the end of the study. (Secondary outcome)
  4. We also hypothesise that BDNF gene modulates mood changes in response to exercise intervention. (Secondary outcome)

Studietype

Intervensjonell

Registrering (Forventet)

272

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
      • Hong Kong, Kina
        • Rekruttering
        • Hong Kong East Cluster, Hospital Authority
        • Hovedetterforsker:
          • Kong Hing Leung
      • Hong Kong, Kina
        • Rekruttering
        • Hong Kong West Cluster, Hospital Authority
        • Ta kontakt med:
        • Hovedetterforsker:
          • Wai Chi Chan
      • Hong Kong, Kina
        • Rekruttering
        • Kowloon West Cluster, Hospital Authority
        • Hovedetterforsker:
          • Karen Wat
      • Hong Kong, Kina
        • Rekruttering
        • New Territories East Cluster, Hospital Authority
        • Hovedetterforsker:
          • Linda Lam
      • Hong Kong, Kina
        • Fullført
        • New Territories West Cluster, Hospital Authority

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Caregivers

  • 18 years of age and above
  • Live with persons with dementia
  • 15-item Geriatric Depression Scale (GDS) >0 and <8
  • No regular (i.e. ≥ 3 times/week) Tai Chi practice or other forms of mind-body exercise (e.g. yoga, qigong, mindfulness training) in the past six months
  • Understand Chinese
  • If they are on an antidepressant, they will not be included in the study unless they have been receiving pharmacological treatment on a steady dose for three months

Care recipient

  • Aged 60 years or above
  • Dementia diagnosis confirmed by a physician
  • Dependence in at least one Activities of daily living(ADL)
  • Mini Mental State Examination (MMSE) > 10
  • No regular (i.e. ≥ 3 times/week) Tai Chi practice or other forms of mind-body exercise (e.g. yoga, qigong, mindfulness training) in the past six months

Exclusion Criteria:

Caregivers

  • Presence of psychotic symptoms, imminently suicidal, unstable medical conditions (e.g. recent heart attack, recent stroke, episodes of dizziness, fainting attacks) or significant orthopaedic problems rendering participants unsuitable for physical training
  • Carers who are found to have mental conditions that warrants psychiatric assessment and/or treatment (e.g. GDS >8, i.e. local cut-off score for significant depressive symptoms, or suicidal) will be referred to appropriate units for follow up

Care recipient

  • Presence of psychotic symptoms, unstable medical conditions (e.g. recent heart attack, recent stroke, episodes of dizziness, fainting attacks) or significant orthopaedic problems rendering participants unsuitable for physical training

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 12-step sitting Tai Chi Chuan
The intervention is a simplified Tai Chi Chuan exercise, which consists of 12 steps, including weight shifting in different sitting positions, trunk and upper limb movements, and alternate thigh lift in a smooth and coordinated manner.
Annen: 12-step sitting Tai Chi Chuan
The intervention consists of eight home-based sessions on 12-step sitting Tai Chi Chuan. Each session will last for an hour.
Placebo komparator: Control
We provide participants in the control group with a level of social contact equivalent to the intervention group, which comprises structured conversations on topic other than physical activity.
Annen: Control
The control consists of eight home-based sessions on useful health-care information. Each session will last for an hour.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline Hamilton Rating Scale for Depression in caregivers
Tidsramme: Week 12
The proportion of participants who are classified as responders by Hamilton Rating Scale for Depression (HAM-D-17). HAM-D-17 is a widely used and reliable measure of depressive symptoms. The scores range from 0 to 52, with higher scores indicating greater depression severity. Response to intervention is defined as a reduction of HAM-D-17 total score by ≥50% from baseline to endpoint.
Week 12

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Berg Balance Scale in caregivers and care recipients
Tidsramme: Week 12
Berg Balance Scale (BBS)
Week 12
Mini Mental State Examination in caregivers and care recipients
Tidsramme: Week 12
Global cognitive function will be measured by Mini Mental State examination (MMSE)
Week 12
Quality of life in caregivers and care recipients
Tidsramme: Week 12
SF-12 Health Survey (SF-12)
Week 12

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The University of Hong Kong

Samarbeidspartnere

Chinese University of Hong Kong
Food and Health Bureau, Hong Kong
University of Melbourne
National Ageing Research Institute, Australia

Etterforskere

  • Hovedetterforsker: Wai Chi Chan, The University of Hong Kong

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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

1. mai 2014

Primær fullføring (Forventet)

1. september 2016

Studiet fullført (Forventet)

1. mars 2017

Datoer for studieregistrering

Først innsendt

28. april 2014

Først innsendt som oppfylte QC-kriteriene

3. mai 2014

Først lagt ut (Anslag)

6. mai 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. mai 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mai 2016

Sist bekreftet

1. mai 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 11121441

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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