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Trial record 48 of 203 for:    strength | Norway

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

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ClinicalTrials.gov Identifier: NCT02905383
Recruitment Status : Active, not recruiting
First Posted : September 19, 2016
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Sylvia Sunde, Oslo and Akershus University College of Applied Sciences

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.

Condition or disease Intervention/treatment Phase
Chest Pain Pneumonia Transient Ischemic Attack Stroke Functional Failure Other: Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
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 Start Date : May 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Changes in physical function [ Time Frame: 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 :
  1. Berg Balance Scale [ Time Frame: 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.

  2. Health-related quality of life (HRQOL) [ Time Frame: Baseline, 4 months and 8 months ]
    HRQOL measured by the Medical Outcome Study 36 Item Short-Form Health Survey (SF-36)

  3. Physical Activity measured by the short form of the International Physical Activity Questionnaire (IPAQ-SF) [ Time Frame: 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.

  4. Muscle mass [ Time Frame: Baseline, 4 months and 8 months ]
    Muscle mass will be measured by bioimpedance

  5. Compliance to the intervention [ Time Frame: 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.

  6. Feasibility of the intervention [ Time Frame: 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.

  7. Amount of home-help services received [ Time Frame: Baseline, 4 months and 8 months ]
    If they receive any home care

  8. Handgrip strength [ Time Frame: Baseline, 4 months and 8 months ]
    Handgrip strength in kilograms measured using a hydraulic dynamometer

  9. Height [ Time Frame: Baseline ]
    Height will be measured in meters



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905383


Locations
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Norway
Diakonhjemmet Hospital
Oslo, Norway, 0370
Sponsors and Collaborators
Oslo and Akershus University College of Applied Sciences
Investigators
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Principal Investigator: Therese Brovold, Phd Oslo University College of Applied Science

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Responsible Party: Sylvia Sunde, Phd-student, Oslo and Akershus University College of Applied Sciences
ClinicalTrials.gov Identifier: NCT02905383     History of Changes
Other Study ID Numbers: 2015/2432
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
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Pneumonia
Chest Pain
Ischemic Attack, Transient
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pain
Neurologic Manifestations
Signs and Symptoms
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases