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

Primary Purpose

Chest Pain, Pneumonia, Transient Ischemic Attack

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercise
Sponsored by
Oslo Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chest Pain

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Diakonhjemmet Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Berg Balance Scale
Berg Balance Scale is a measure of performance-based balance. It comprises 14 observable tasks frequently encountered in everyday life.
Health-related quality of life (HRQOL)
HRQOL measured by the Medical Outcome Study 36 Item Short-Form Health Survey (SF-36)
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.
Muscle mass
Muscle mass will be measured by bioimpedance
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.
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.
Amount of home-help services received
If they receive any home care
Handgrip strength
Handgrip strength in kilograms measured using a hydraulic dynamometer
Height
Height will be measured in meters

Full Information

First Posted
September 5, 2016
Last Updated
August 3, 2020
Sponsor
Oslo Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT02905383
Brief Title
The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital
Acronym
OLPADIS
Official Title
Effect of a Multi-Component Exercise Program on Function and Health in Older People Recently Discharged From Hospital. A Randomized Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 29, 2016 (undefined)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo Metropolitan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Pneumonia, Transient Ischemic Attack, Stroke, Functional Failure

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
A multi-component exercise program that consists of endurance training, progressive strength exercises and balance exercises.
Primary Outcome Measure Information:
Title
Changes in physical function
Description
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.
Time Frame
Baseline, 4 months and 8 months
Secondary Outcome Measure Information:
Title
Berg Balance Scale
Description
Berg Balance Scale is a measure of performance-based balance. It comprises 14 observable tasks frequently encountered in everyday life.
Time Frame
Baseline, 4 months and 8 months
Title
Health-related quality of life (HRQOL)
Description
HRQOL measured by the Medical Outcome Study 36 Item Short-Form Health Survey (SF-36)
Time Frame
Baseline, 4 months and 8 months
Title
Physical Activity measured by the short form of the International Physical Activity Questionnaire (IPAQ-SF)
Description
The IPAQ-SF includes seven questions about the time spent in vigorous- and moderate intensity activities, walking and sedentary activity.
Time Frame
Baseline, 4 months and 8 months
Title
Muscle mass
Description
Muscle mass will be measured by bioimpedance
Time Frame
Baseline, 4 months and 8 months
Title
Compliance to the intervention
Description
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.
Time Frame
Eight months from baseline
Title
Feasibility of the intervention
Description
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.
Time Frame
Four months from baseline
Title
Amount of home-help services received
Description
If they receive any home care
Time Frame
Baseline, 4 months and 8 months
Title
Handgrip strength
Description
Handgrip strength in kilograms measured using a hydraulic dynamometer
Time Frame
Baseline, 4 months and 8 months
Title
Height
Description
Height will be measured in meters
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Therese Brovold, Phd
Organizational Affiliation
Oslo University College of Applied Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diakonhjemmet Hospital
City
Oslo
ZIP/Postal Code
0370
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
34106446
Citation
Sunde S, Hesseberg K, Skelton DA, Ranhoff AH, Pripp AH, Aaronaes M, Brovold T. Associations between health-related quality of life and physical function in older adults with or at risk of mobility disability after discharge from the hospital. Eur Geriatr Med. 2021 Dec;12(6):1247-1256. doi: 10.1007/s41999-021-00525-0. Epub 2021 Jun 9.
Results Reference
derived
PubMed Identifier
33176703
Citation
Sunde S, Hesseberg K, Skelton DA, Ranhoff AH, Pripp AH, Aaronaes M, Brovold T. Effects of a multicomponent high intensity exercise program on physical function and health-related quality of life in older adults with or at risk of mobility disability after discharge from hospital: a randomised controlled trial. BMC Geriatr. 2020 Nov 11;20(1):464. doi: 10.1186/s12877-020-01829-9.
Results Reference
derived

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

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