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 : July 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chest Pain Pneumonia Transient Ischemic Attack Stroke Functional Failure||Other: Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|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 :||September 29, 2016|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
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.
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.
- 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.
- 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.
- 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)
- 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.
- Muscle mass [ Time Frame: Baseline, 4 months and 8 months ]Muscle mass will be measured by bioimpedance
- 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.
- 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.
- Amount of home-help services received [ Time Frame: Baseline, 4 months and 8 months ]If they receive any home care
- Handgrip strength [ Time Frame: Baseline, 4 months and 8 months ]Handgrip strength in kilograms measured using a hydraulic dynamometer
- Height [ Time Frame: Baseline ]Height will be measured in meters
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
|Oslo, Norway, 0370|
|Principal Investigator:||Therese Brovold, Phd||Oslo University College of Applied Science|