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

Not Applicable

Completed

• Conditions: Pneumonia; Transient Ischemic Attack; Chest Pain; Stroke; Functional Failure

• Registration Number: NCT02905383
• Lead Sponsor: Oslo Metropolitan University

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.

Study Timeline

• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-19
• Study Start: 2016-09-29
• Primary Completion: 2020-01-30
• Study Completion: 2020-01-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in physical function	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 Outcome Measures

Name	Time	Method
Berg Balance Scale	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.
Feasibility of the intervention	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.
Physical Activity measured by the short form of the International Physical Activity Questionnaire (IPAQ-SF)	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.
Muscle mass	Baseline, 4 months and 8 months	Muscle mass will be measured by bioimpedance
Amount of home-help services received	Baseline, 4 months and 8 months	If they receive any home care
Health-related quality of life (HRQOL)	Baseline, 4 months and 8 months	HRQOL measured by the Medical Outcome Study 36 Item Short-Form Health Survey (SF-36)
Compliance to the intervention	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.
Handgrip strength	Baseline, 4 months and 8 months	Handgrip strength in kilograms measured using a hydraulic dynamometer
Height	Baseline	Height will be measured in meters

Trial Locations

Locations (1)

Diakonhjemmet Hospital; 🇳🇴 Oslo, Norway