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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Pneumonia; Transient Ischemic Attack; Chest Pain; Functional Failure
• Intervention / Treatment: Other: Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0370
    • Diakonhjemmet Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise; 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; A multi-component exercise program that consists of endurance training, progressive strength exercises and balance exercises.
No Intervention: Control; 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?

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

Collaborators and Investigators

• Sponsor: Oslo Metropolitan University
• Investigators: Principal Investigator: Therese Brovold, Phd, Oslo University College of Applied Science

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 29, 2016
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: September 5, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 19, 2016

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Brain Ischemia; Ischemic Attack, Transient; Chest Pain
• Other Study ID Numbers: 2015/2432