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ThinkingFit: Combined Physical, Cognitive and Social Treatment in Mild Cognitive Impairment (MCI) (ThinkingFit)

25 april 2014 bijgewerkt door: Dr Thomas Dannhauser

Piloting a Complex Intervention Involving Physical Exercise, Cognitive Training and Socialising to Delay the Onset of Dementia in Mild Cognitive Impairment

Dementia is serious problem and around 700 000 people are affected in the UK alone. Currently there is no cure however early diagnosis and effective treatment offers hope for reducing the impact. Dementia sufferers require care due to physical disability, cognitive deficits, social isolation and emotional symptoms (depression). Delaying the onset of dementia will improve quality of life for patients and reduce the cost of residential care (£42 000 per person per year).

People with mild cognitive impairment (MCI) are at high risk of developing dementia. They have impaired cognitive abilities, such as memory, but still manage their everyday activities. Studies show that 8 out of 10 people with MCI will have developed dementia 6 years after diagnosis.

Regular physical activities and performing a variety of cognitive activities reduce the risk of dementia and improves abilities and quality of life in healthy people. Therefore a combination of these activities may reduce the risk of developing dementia in MCI. The investigators want to see if they can develop a program which combines these activities in a fun and social way that gets people active and keeps them active. The aims are to improve fitness, cognition and quality of life. The investigators plan to use computers and the internet to help with the activities and to make them available to people who are isolated. Physical activity will involve walking from home, cognitive activities will be computer based games and puzzles and socialising will involve regular varied group-based activities. Participants (128) will be recruited from the UCL Derwent Memory Clinic and will complete a 26 week program. They will then be followed up yearly to monitor their progress. The main outcome of the study is engagement in the activities. The investigators will also measure fitness, cognition, quality of life and conversion to dementia.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Verwacht)

128

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigd Koninkrijk
    • Essex
      • Harlow, Essex, Verenigd Koninkrijk, cm20 1qx
        • North Essex Partnership Foundation NHS Trust

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion criteria for patients with MCI

  1. Patients fulfilling criteria for AMCI [Petersen et al. 2001b]:

    i. Memory impairment for age and education ii. No impairment in other cognitive domains iii. Normal social activities iv. Patient is not demented

  2. For the other subtypes of MCI, cognitive impairment in one or more nonmemory domain
  3. Sedentary lifestyle with no regular participation in physical exercise defined as two or three times a week for at least 20 minutes duration, or participation in active sport more than once a week, in the previous six months.
  4. Willing and able to give informed consent.
  5. Availability and access to safe exercise environments, such as paths or roads with sidewalks for walking or cycling.
  6. At low risk from serious adverse effects from increased physical activity as indicated by performance on the revised Physical activity readiness questionnaire (PARQ).

Exclusion Criteria:

Exclusion criteria for patients with MCI

  1. Type 1 (insulin dependent) diabetes mellitus.
  2. Blood pressure of 160/100 mmHg or more.
  3. Body weight more than 140% of ideal body weight.
  4. Musculoskeletal or other medical problems preventing safe participation in regular moderate intensity exercise (65-77% of predicted maximum heart rate). This will include a resting tachycardia (heart rate above 100 bpm) and history of myocardial infarction or unstable angina within the last month.

Participants with modifiable exclusion criteria will be reconsidered after successful management. Patients will be referred for medical treatment prior to commencing exercise if indicated by the PARQ and the intervention will be guided by the PARmedX.

Participants taking medications affecting heart rate will need to be on a stable dosing regime for 3 months prior to commencing in order to control for potential spurious results on fitness measures caused by these treatments.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: ThinkingFit
Procedure: ThinkingFit programme
Combined physical, cognitive and social stimulation activties.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Activity Compliance
Tijdsspanne: Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks
Number of participants to have completed 50% or more of the programmed activity sessions during the intervention period.
Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cardiovascular fitness measure
Tijdsspanne: This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.
Cardiovascular fitness will be measured with a modified Siconolfi Step Test.
This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.
Cognitive measures
Tijdsspanne: This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.

Participants will complete the following cognitive measures:

  • Visual and auditory divided attention task
  • Verbal episodic encoding and recognition task
  • Halstead Trail Making test (TMT)
  • Verbal fluency
  • Working memory tests: digit span forwards/ backwards
This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.
Measures of quality of life and everyday activities
Tijdsspanne: This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.
Quality of life will be measured on the World Health Organization Quality of Life (WHOQOL) - BREF and change in every day activities on the Alzheimer's Disease Cooperative Study MCI Activities of Daily Living Scale (ADCS-MCI-ADL)
This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Dr Thomas Dannhauser

Medewerkers

University College, London

Onderzoekers

  • Hoofdonderzoeker: Martin Cleverley, North Essex Partnership Foundation NHS Trust
  • Studie directeur: Thomas M Dannhauser, PhD, University College London, North Essex Partnership NHS Foundation Trust

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2010

Primaire voltooiing (Werkelijk)

1 november 2012

Studie voltooiing (Werkelijk)

1 november 2012

Studieregistratiedata

Eerst ingediend

17 mei 2012

Eerst ingediend dat voldeed aan de QC-criteria

20 mei 2012

Eerst geplaatst (Schatting)

23 mei 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

28 april 2014

Laatste update ingediend die voldeed aan QC-criteria

25 april 2014

Laatst geverifieerd

1 april 2014

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ThinkingFit 1

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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