Can Primary Care Change Elderly Physical Activity and Salt Intake? An Australian Pilot Trial

Study Overview
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Brief Summary
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A randomised controlled trial to test if offering three visits to a dietician + two visits to a physiotherapist over six months + a home sphygmomanometer, will result in a reduction in sodium intake and an increase in fitness in people over 75yrs. Volunteers were enrolled from Oct 2008 to July 2009.

Detailed Description
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There is evidence that both sedentary lifestyle and high sodium diets contribute to cardiovascular disease and possibly dementia among the elderly. There is a need to show that minimal intervention can reduce sodium intake and increase fitness in the elderly. Finland has shown that five dietician visits/year could change diet in respect to fat and fibre. In Australia the National Health Insurer (Medicare) funds five allied health visits/year for those with chronic disease, hence our use of this model. This is consistent with WHO guidelines for a national approach using existing health infrastructure. The elderly (75-95yrs) were chosen as this group is thought most difficult to change behaviour and has a higher incidence of dementia.

Official Title
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Effective Change of Behaviour of the Elderly in Normal General Practice

Conditions
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Health Behaviour

Intervention / Treatment
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* Behavioral: Lifestyle counselling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Living independently Must be able to walk for six minutes Exclusion Criteria: Dementia as defined by Standardised Mini-Mental State Examination score <25/30 All patients of HealthHQ-Southport General Practice

Ages Eligible for Study
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Minimum Age: 75 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counselling<br>Three dietician visits focussed on education to find food with sodium less than 120mg/100gms. Two physiotherapist visits focussed on teaching personalised sustainable practical exercise. | Behavioral: Lifestyle counselling<br>* as in Arm Description<br>* Other names: increased fitness in the elderly;|
| No Intervention: Control<br>Control group was offered free skin cancer check and wait listed for the same lifestyle counselling after the six months of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change in morning urine sodium/potassium ratio | this measure is to reflect sodium intake. A 24hr urinary sodium cannot be readily validated as an accurate collection and even in the Trials of Hypertension Prevention study was changed to 8hrs to assist compliance. A spot morning ratio is a useful marker of sodium intake for group evaluation. | between enrollment and six months | 
| the increased distance in a six minute walk test | to measure objectively an increase in fitness the increase in the six minute walk test was used | between enrollment and six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in systolic BP | teaching people to reduce sodium intake and increase fitness may reduce systolic blood pressure as a secondary outcome | between enrollment and six months | 
| change in doses/day of antihypertensive medication | teaching reduction in sodium and increased fitness may mean people need less antihypertensive medication as a secondary outcome | between enrollment and six months | 
| change in waist measurement | teaching increased fitness would be expected to reduce waist measurement as a secondary outcome | between enrollment and six months | 
| change in weight & BMI | teaching increased fitness would be expected to reduce weight and therefore calculated Body Mass Index as a secondary outcome | between enrollment and six months | 
| change in cognition measurement | Cognition measurements using the Standardised Mini-Mental State Examination, and the more comprehensive and sensitive Addenbrooke Cognitive Examination to compare those in the intervention group with the highest and lowest quartiles of reduction in sodium intake + increased fitness (equally weighted), as a secondary outcome of teaching these lifestyle changes. | between enrollment and six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Sodium reduction, Fitness increase, Primary Care