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

Stroke Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02905383
• Other study ID #: 2015/2432
• Status: Completed
• Phase: N/A
• Start date: September 29, 2016
• Est. completion date: January 30, 2020

Study information

• Verified date: August 2020
• Source: Oslo Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Norway	Diakonhjemmet Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo Metropolitan University

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Muscle mass	Muscle mass will be measured by bioimpedance	Baseline, 4 months and 8 months
Secondary	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
Secondary	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
Secondary	Amount of home-help services received	If they receive any home care	Baseline, 4 months and 8 months
Secondary	Handgrip strength	Handgrip strength in kilograms measured using a hydraulic dynamometer	Baseline, 4 months and 8 months
Secondary	Height	Height will be measured in meters	Baseline