Clinical trial NCT02905383: The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital
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
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Pneumonia
Transient Ischemic Attack
Stroke
Functional Failure
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 88
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Changes in physical function
timeFrame: Baseline, 4 months and 8 months
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: Baseline, 4 months and 8 months
measure: Health-related quality of life (HRQOL)
timeFrame: Baseline, 4 months and 8 months
measure: Physical Activity measured by the short form of the International Physical Activity Questionnaire (IPAQ-SF)
timeFrame: Baseline, 4 months and 8 months
measure: Muscle mass
timeFrame: Baseline, 4 months and 8 months
measure: Compliance to the intervention
timeFrame: Eight months from baseline
measure: Feasibility of the intervention
timeFrame: Four months from baseline
measure: Amount of home-help services received
timeFrame: Baseline, 4 months and 8 months
measure: Handgrip strength
timeFrame: Baseline, 4 months and 8 months
measure: Height
timeFrame: Baseline
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
Study officials:
affiliation: Oslo University College of Applied Science
name: Therese Brovold, Phd
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.