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CompletedNCT02905383OLPADISUpdated Aug 4, 2020

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

An interventional study of Exercise in Chest Pain, Pneumonia and Transient Ischemic Attack, sponsored by Oslo Metropolitan University. Completed at 1 site in Norway. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-04.

Sponsored by Oslo Metropolitan University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chest Pain
  • Pneumonia
  • Transient Ischemic Attack
  • Stroke
  • Functional Failure
03

In context

Ischemic Attack, Transient

293 studies on the registry are indexed under Ischemic Attack, Transient; 64 are open to participants now.

This study's enrollment of 88 is below the median of 206 across 164 interventional studies indexed under Ischemic Attack, Transient.

Browse Ischemic Attack, Transient studies →

Lead sponsor

Oslo Metropolitan University is the lead sponsor of 64 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
88 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • OtherExercise

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 4 months and 8 months

Secondary outcomes

  1. Berg Balance Scale

    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

  2. Health-related quality of life (HRQOL)

    HRQOL measured by the Medical Outcome Study 36 Item Short-Form Health Survey (SF-36)

    Time frame: Baseline, 4 months and 8 months

  3. 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.

    Time frame: Baseline, 4 months and 8 months

  4. Muscle mass

    Muscle mass will be measured by bioimpedance

    Time frame: Baseline, 4 months and 8 months

  5. 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.

    Time frame: Eight months from baseline

  6. 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.

    Time frame: Four months from baseline

  7. Amount of home-help services received

    If they receive any home care

    Time frame: Baseline, 4 months and 8 months

  8. Handgrip strength

    Handgrip strength in kilograms measured using a hydraulic dynamometer

    Time frame: Baseline, 4 months and 8 months

  9. Height

    Height will be measured in meters

    Time frame: Baseline

07

Study locations

1 site
  • Diakonhjemmet Hospital
    Oslo, 0370, Norway
08

References and documents

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. PubMed 34106446 ↗
  • 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. PubMed 33176703 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02905383
Lead sponsor
Oslo Metropolitan University
Responsible party
Sylvia Sunde (Phd-student, Oslo Metropolitan University) — Principal investigator
First posted
Sep 19, 2016
Start date
Sep 29, 2016
Primary completion
Jan 30, 2020
Completion
Jan 30, 2020
Last update
Aug 4, 2020

Study contacts

Therese Brovold, Phd
principal investigator · Oslo University College of Applied Science

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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