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NCT Number: NCT02905383

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

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.

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Key information

Conditions

Chest Pain Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Functional Failure Infections Ischemic Attack, Transient Lung Diseases Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Stroke Transient Ischemic Attack Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diakonhjemmet Hospital

Oslo, 0370, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

A multi-component exercise program that consists of endurance training, progressive strength exercises and balance exercises.

Primary outcomes

  1. Changes in physical function

    Time frame: Baseline, 4 months and 8 months

    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.

Secondary outcomes

  1. Berg Balance Scale

    Time frame: Baseline, 4 months and 8 months

    Berg Balance Scale is a measure of performance-based balance. It comprises 14 observable tasks frequently encountered in everyday life.

  2. Health-related quality of life (HRQOL)

    Time frame: Baseline, 4 months and 8 months

    HRQOL measured by the Medical Outcome Study 36 Item Short-Form Health Survey (SF-36)

  3. Physical Activity measured by the short form of the International Physical Activity Questionnaire (IPAQ-SF)

    Time frame: Baseline, 4 months and 8 months

    The IPAQ-SF includes seven questions about the time spent in vigorous- and moderate intensity activities, walking and sedentary activity.

  4. Muscle mass

    Time frame: Baseline, 4 months and 8 months

    Muscle mass will be measured by bioimpedance

  5. Compliance to the intervention

    Time frame: Eight months from baseline

    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.

  6. Feasibility of the intervention

    Time frame: Four months from baseline

    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.

  7. Amount of home-help services received

    Time frame: Baseline, 4 months and 8 months

    If they receive any home care

  8. Handgrip strength

    Time frame: Baseline, 4 months and 8 months

    Handgrip strength in kilograms measured using a hydraulic dynamometer

  9. Height

    Time frame: Baseline

    Height will be measured in meters

Sponsors and collaborators

Lead sponsor

Oslo Metropolitan University

Other

Registry information

Official study title

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

Acronym: OLPADIS

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 19, 2016
Registry last updated
Aug 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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