The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital

Study Overview
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Brief Summary
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The aim of this study is to investigate the effect of a multi-component exercise program on physical function, physical activity and health-related quality of life (HRQOL) in older people recently discharged from hospital. The intervention consists of 32 group-based exercise sessions, performed twice a week. In addition the participants in the intervention group will be encouraged to perform an exercise program on their own, at least once weekly. The participants in the control group will be encouraged to exercise on their own, according to the World Health Organization (WHO) recommendations on physical activity for adults aged 65 and above.

Detailed Description
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Older people who have been hospitalized often experience loss of function, increased risk of falls and reduced health-related quality of life (HRQOL) in the post-discharge period. The reason for this is the cumulative effect of illness, bedrest during hospital stay and inactivity after discharge. Previous research indicates that exercise therapy should be an integrated part of the post-hospital treatment to prevent or postpone this functional decline and improve HRQOL. Therefore, the investigators will conduct a randomized controlled trial to investigate the effect of a multi-component exercise program consisting of high intensity exercises on physical function, physical activity and HRQOL among older people living at home after discharge from hospital after treatment of an acute medical event.

Official Title
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Effect of a Multi-Component Exercise Program on Function and Health in Older People Recently Discharged From Hospital. A Randomized Controlled Clinical Trial.

Conditions
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Chest Pain, Pneumonia, Transient Ischemic Attack, Stroke, Functional Failure

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 65 years or older, live in their own home, consent to participate in the program three times a week (twice a week outside their home), manage to walk with or without assistive device, and assessed by a doctor as able to tolerate the intervention. Exclusion Criteria: Severe cognitive impairment (Mini-Mental State Examination (MMSE) score less than 20), have an expected lifespan less than one year, exercise more than twice a week, and score above nine points on the Short Physical Performance Battery.

Ages Eligible for Study
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Minimum Age: 65 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>This group will perform a multi-component exercise program twice a week for 16 weeks. The multi-component exercise program consists of endurance training, progressive strength exercises and balance exercises. The intervention will be individualised, but performed in groups of four to ten patients. The participants are also expected to do exercises on their own, at least once weekly. | Other: Exercise<br>* A multi-component exercise program that consists of endurance training, progressive strength exercises and balance exercises.<br>|
| No Intervention: Control<br>The participants in the control group will be encouraged to exercise on their own, according to the World Health Organization recommendations on physical activity for adults aged 65 and above. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in physical function | Changes in physical function will be measured with The Short Physical Performance Battery (SPPB). This test evaluates balance, mobility and muscle strength by examining an individual's ability to stand with feet together side-by side, semitandem and tandem positions, time to walk 8ft and time to rise from a chair and return to the seated position five times. Each of the three tests is scored, based on performance between 0 and 4, leaving a maximum score of 12 for those individuals performing at the highest levels. | Baseline, 4 months and 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale | Berg Balance Scale is a measure of performance-based balance. It comprises 14 observable tasks frequently encountered in everyday life. | Baseline, 4 months and 8 months | 
| Health-related quality of life (HRQOL) | HRQOL measured by the Medical Outcome Study 36 Item Short-Form Health Survey (SF-36) | Baseline, 4 months and 8 months | 
| Physical Activity measured by the short form of the International Physical Activity Questionnaire (IPAQ-SF) | The IPAQ-SF includes seven questions about the time spent in vigorous- and moderate intensity activities, walking and sedentary activity. | Baseline, 4 months and 8 months | 
| Muscle mass | Muscle mass will be measured by bioimpedance | Baseline, 4 months and 8 months | 
| Compliance to the intervention | Participants will complete an activity diary where they are asked to report completion of exercise, non-protocol activity and any adverse events related to the exercise. Patients are considered non-compliant if they have undertaken less than 50% of the prescribed exercise. | Eight months from baseline | 
| Feasibility of the intervention | Adverse events will be registered as outlined by Oryet al. (2005) in the following four categories: falls, cardiovascular events, musculoskeletal injuries and health care utilization. | Four months from baseline | 
| Amount of home-help services received | If they receive any home care | Baseline, 4 months and 8 months | 
| Handgrip strength | Handgrip strength in kilograms measured using a hydraulic dynamometer | Baseline, 4 months and 8 months | 
| Height | Height will be measured in meters | Baseline |