ThinkingFit: Combined Physical, Cognitive and Social Treatment in Mild Cognitive Impairment (MCI) (ThinkingFit)
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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Várható)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Essex
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Harlow, Essex, Egyesült Királyság, cm20 1qx
- North Essex Partnership Foundation NHS Trust
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion criteria for patients with MCI
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
- For the other subtypes of MCI, cognitive impairment in one or more nonmemory domain
- 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.
- Willing and able to give informed consent.
- Availability and access to safe exercise environments, such as paths or roads with sidewalks for walking or cycling.
- 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
- Type 1 (insulin dependent) diabetes mellitus.
- Blood pressure of 160/100 mmHg or more.
- Body weight more than 140% of ideal body weight.
- 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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: ThinkingFit
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Combined physical, cognitive and social stimulation activties.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Activity Compliance
Időkeret: Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks
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Number of participants to have completed 50% or more of the programmed activity sessions during the intervention period.
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Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Cardiovascular fitness measure
Időkeret: This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.
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Cardiovascular fitness will be measured with a modified Siconolfi Step Test.
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This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.
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Cognitive measures
Időkeret: This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.
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Participants will complete the following cognitive measures:
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This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.
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Measures of quality of life and everyday activities
Időkeret: This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.
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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)
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This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.
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Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Martin Cleverley, North Essex Partnership Foundation NHS Trust
- Tanulmányi igazgató: Thomas M Dannhauser, PhD, University College London, North Essex Partnership NHS Foundation Trust
Publikációk és hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- ThinkingFit 1
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