Abstract
Background
Approximately 670,000 people in the UK have dementia. Previous literature suggests physical exercise could slow dementia symptom progression.
Objectives
To estimate the clinical and cost-effectiveness of a bespoke exercise programme, in addition to usual care, on the cognitive impairment (primary outcome), function and health-related quality of life (HRQoL) of people with mild to moderate dementia (MMD), and carer burden and HRQoL.
Design
Intervention development, systematic review, multi-centred, RCT with parallel economic evaluation and qualitative study.
Setting
15 English regions
Participants
People with MMD living in the community.
Intervention
4-month moderate to high intensity, structured exercise programme designed specifically for people with MMD with support to continue unsupervised physical activity thereafter. Exercises were individually prescribed and progressed and participants were supervised in groups. The comparator was usual practice.
Main outcome measures
Alzheimer’s disease Assessment Scale – Cognitive Subscale (ADAS-Cog). Secondary outcomes were function (Bristol Activities of Daily Living Scale), generic HRQoL (EQ-5D-3L), dementia related QoL (QoL-AD), behavioural symptoms (Neuropsychiatric Inventory), physical fitness (6MWT) and muscle strength. Carer outcomes were EQ-5D-3L and carer burden (Zarit Burden Inventory). Economic evaluation was expressed in terms of incremental cost per quality-adjusted life year (QALY) gained from a NHS and Personal Social Services perspective. Participants were followed up for 12 months.
Results
Between February 2013 and June 2015, 494 participants were randomised with an intentional unequal allocation ratio: 165 to usual care, 329 the intervention. The mean age of participants was 77 (SD 7.9) years, 39% (193/494) were female and mean baseline ADAS-Cog score was 21.5 (SD 9.0). Participants in the intervention arm achieved high compliance rates with 65% (214/329) attending between 75-100% of sessions. Outcome data were obtained for 85% (418/494) at 12 months where a small, statistically significant negative treatment effect was found in the primary outcome, ADAS-Cog (patient reported), mean difference (MD) -1.4 (95% Confidence Intervals (CI) -2.62, -0.17). There were no treatment effects for any of the other secondary outcome measures for participants or carers: BADLS MD -0.6 (95% CI -2.05, 0.78), EQ-5D-3L MD -0.002 (95% CI -0.04, 0.04), QoL-AD MD 0.7 (95% CI -0.21, 1.65), NPI MD -2.1 (95% CI -4.83, 0.65). There were 4 SAEs reported. The Exercise intervention was dominated in health economic terms.
Limitations
In the absence of definitive guidance and rationale, we used a mixed exercise programme. The inability to mask participants and treating therapists to allocation was unavoidable.
Conclusions
This is a large well-conducted RCT with good compliance to exercise and research procedures. A structured exercise programme did not produce any clinically meaningful benefit in function and HRQoL of people with dementia, or on carer burden
Future work
Should concentrate on approaches other than exercise to influence cognitive impairment in dementia.
Approximately 670,000 people in the UK have dementia. Previous literature suggests physical exercise could slow dementia symptom progression.
Objectives
To estimate the clinical and cost-effectiveness of a bespoke exercise programme, in addition to usual care, on the cognitive impairment (primary outcome), function and health-related quality of life (HRQoL) of people with mild to moderate dementia (MMD), and carer burden and HRQoL.
Design
Intervention development, systematic review, multi-centred, RCT with parallel economic evaluation and qualitative study.
Setting
15 English regions
Participants
People with MMD living in the community.
Intervention
4-month moderate to high intensity, structured exercise programme designed specifically for people with MMD with support to continue unsupervised physical activity thereafter. Exercises were individually prescribed and progressed and participants were supervised in groups. The comparator was usual practice.
Main outcome measures
Alzheimer’s disease Assessment Scale – Cognitive Subscale (ADAS-Cog). Secondary outcomes were function (Bristol Activities of Daily Living Scale), generic HRQoL (EQ-5D-3L), dementia related QoL (QoL-AD), behavioural symptoms (Neuropsychiatric Inventory), physical fitness (6MWT) and muscle strength. Carer outcomes were EQ-5D-3L and carer burden (Zarit Burden Inventory). Economic evaluation was expressed in terms of incremental cost per quality-adjusted life year (QALY) gained from a NHS and Personal Social Services perspective. Participants were followed up for 12 months.
Results
Between February 2013 and June 2015, 494 participants were randomised with an intentional unequal allocation ratio: 165 to usual care, 329 the intervention. The mean age of participants was 77 (SD 7.9) years, 39% (193/494) were female and mean baseline ADAS-Cog score was 21.5 (SD 9.0). Participants in the intervention arm achieved high compliance rates with 65% (214/329) attending between 75-100% of sessions. Outcome data were obtained for 85% (418/494) at 12 months where a small, statistically significant negative treatment effect was found in the primary outcome, ADAS-Cog (patient reported), mean difference (MD) -1.4 (95% Confidence Intervals (CI) -2.62, -0.17). There were no treatment effects for any of the other secondary outcome measures for participants or carers: BADLS MD -0.6 (95% CI -2.05, 0.78), EQ-5D-3L MD -0.002 (95% CI -0.04, 0.04), QoL-AD MD 0.7 (95% CI -0.21, 1.65), NPI MD -2.1 (95% CI -4.83, 0.65). There were 4 SAEs reported. The Exercise intervention was dominated in health economic terms.
Limitations
In the absence of definitive guidance and rationale, we used a mixed exercise programme. The inability to mask participants and treating therapists to allocation was unavoidable.
Conclusions
This is a large well-conducted RCT with good compliance to exercise and research procedures. A structured exercise programme did not produce any clinically meaningful benefit in function and HRQoL of people with dementia, or on carer burden
Future work
Should concentrate on approaches other than exercise to influence cognitive impairment in dementia.
| Original language | English |
|---|---|
| Pages (from-to) | 1-201 |
| Number of pages | 201 |
| Journal | Health Technology Assessment |
| Volume | 22 |
| Issue number | 28 |
| DOIs | |
| Publication status | Published - 1 May 2018 |
Bibliographical note
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- Health Policy
