Chest PainOLPADISNCT02905383
The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital
A study testing Exercise in people with Chest Pain and Pneumonia, run by Oslo Metropolitan University at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chest Pain, Pneumonia, Transient Ischemic Attack
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteNorway
- Study dates
- 29 Sep 2016to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Chest Pain, Pneumonia, Transient Ischemic Attack, Stroke, Functional Failure
- Being tested
- Exercise
- Medical subject headings
- Chest Pain, Pneumonia, Ischemic Attack, Transient, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
A multi-component exercise program that consists of endurance training, progressive strength exercises and balance exercises.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 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. Receives: Other: Exercise |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 months and 8 months
Secondary outcomes (9)
Berg Balance Scale
Berg Balance Scale is a measure of performance-based balance. It comprises 14 observable tasks frequently encountered in everyday life.
Measured: Baseline, 4 months and 8 months
Health-related quality of life (HRQOL)
HRQOL measured by the Medical Outcome Study 36 Item Short-Form Health Survey (SF-36)
Measured: Baseline, 4 months and 8 months
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.
Measured: Baseline, 4 months and 8 months
Muscle mass
Muscle mass will be measured by bioimpedance
Measured: Baseline, 4 months and 8 months
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.
Measured: Eight months from baseline
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.
Measured: Four months from baseline
Amount of home-help services received
If they receive any home care
Measured: Baseline, 4 months and 8 months
Handgrip strength
Handgrip strength in kilograms measured using a hydraulic dynamometer
Measured: Baseline, 4 months and 8 months
Height
Height will be measured in meters
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start29 Sep 2016
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvia Sunde, Oslo Metropolitan University
- Investigators
- Therese Brovold, Phd, Principal investigator, Oslo University College of Applied Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905383
- Sponsor's protocol ID
- 2015/2432
- Acronym
- OLPADIS
- Status last verified
- Aug 2020
- First submitted
- 5 Sep 2016
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
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 34106446Sunde 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02905383
- Acronym / sponsor ID
- OLPADIS / 2015/2432
- Conditions
- Chest Pain, Pneumonia, Transient Ischemic Attack, Stroke, Functional Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Study start
- 29 Sep 2016
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseThis 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseA multi-component exercise program that consists of endurance training, progressive strength exercises and balance exercises. | Other | Exercise |
Primary outcome
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.
9 secondary outcomes
Berg Balance Scale
Time frame: Baseline, 4 months and 8 months
Health-related quality of life (HRQOL)
Time frame: Baseline, 4 months and 8 months
Physical Activity measured by the short form of the International Physical Activity Questionnaire (IPAQ-SF)
Time frame: Baseline, 4 months and 8 months
Muscle mass
Time frame: Baseline, 4 months and 8 months
Compliance to the intervention
Time frame: Eight months from baseline
Feasibility of the intervention
Time frame: Four months from baseline
Amount of home-help services received
Time frame: Baseline, 4 months and 8 months
Handgrip strength
Time frame: Baseline, 4 months and 8 months
Height
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Derived from this study: PubMed 34106446Sunde 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.
- Derived from this study: PubMed 33176703Sunde 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Therese Brovold, Phd principal investigator
Oslo University College of Applied Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Chest Pain and Pneumonia, run by Oslo Metropolitan University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in physical function (time frame: Baseline, 4 months and 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02905383, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.