Coronary Artery DiseaseNCT02025257
Effects of Exercise in Patients With Coronary Artery Disease Aged 80 Years or Older
A study testing Exercise in people with Coronary Artery Disease, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate the effects of exercise for patients with coronary artery disease (CAD) aged 80 years and older, with special reference to maximum aerobic capacity, muscle endurance, physical functioning, level of physical activity, health related quality of life, anxiety, depression and… Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2013to Apr 2022
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Clinical diagnosis of acute coronary artery disease
- Aged 80 years or older
Who cannot join
- Inability to understand or speak the Swedish language
- Serious physical or psychological disease interfering with participation in an exercise intervention
- Patients are already exercising three times or more/week
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of physiotherapy, Sahlgrenska University Hospital
Gothenburg, Select A State…, 41345
About this study
Official title: Effects of Exercise in Patients With Coronary Artery Disease Aged 80 Years or Older - a Randomized Controlled Trial
The purpose of this study is to investigate the effects of exercise for patients with coronary artery disease (CAD) aged 80 years and older, with special reference to maximum aerobic capacity, muscle endurance, physical functioning, level of physical activity, health related quality of life, anxiety, depression and endothelial function, compared to a control group.
- Conditions
- Coronary Artery Disease
- Being tested
- Exercise
- Keywords
- coronary artery disease, elderly, exercise, exercise-based cardiac rehabilitation
- Medical subject headings
- Coronary Artery Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Individually prescribed hospital based exercise in group two times a week, home-based exercise once a week. The exercise intervention consists of interval based aerobic exercise on a bicycle ergometer 30 minutes with intensity level at 13-17 at Borg scale, resistance exercises and balance exercises
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Individually prescribed hospital based exercise in group two times a week, home-based exercise once a week. The exercise intervention consists of interval based aerobic exercise on a bicycle ergometer 30 minutes with intensity level at 13-17 at Borg scale, resistance exercises and balance exercises Receives: Other: Exercise |
| Control | No intervention | Patients are asked to live as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximum aerobic capacity
A maximum exercise test on an electronically braked cycle ergometer, with watts as marker of maximum aerobic capacity.
Measured: At baseline and after 4 months
Secondary outcomes (7)
Change in level of physical activity
Level of physical activity will be measured by an accelerometer and an activity diary
Measured: At baseline and after 4 months
Change in muscular endurance
Will be measured by three clinical endurance tests including unilateral isotonic heel lift, unilateral isotonic shoulder flexion, bilateral isometric shoulder abduction
Measured: At baseline and after 4 months
Change in physical functioning
Including tests of balance: short physical performance battery, one leg standing, timed up and go, and the activities specific balance confidence scale.
Measured: At baseline and after 4 months
Change in health related quality of life
measured by a self-rated health questionnaire
Measured: At baselline and after 4 months
Change in anxiety and depression
measured by the hospital anxiety and depression scale
Measured: At baseline and after 4 months
Change in endothelial function
Evaluated with non-invasive ultrasound
Measured: At baseline and after 4 months
Change in transthoracic evaluation of resting coronary flow velocity
Measured: At baseline and after 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionMay 2019
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Bäck, Sahlgrenska University Hospital
- Investigators
- Maria Bäck, PhD, Principal investigator, Department of Physiotherapy, Sahlgrenska University Hospital, Gothenburg, SwedenPer Albertsson, PhD, Study chair, Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025257
- Sponsor's protocol ID
- 462-13
- Status last verified
- Apr 2022
- First submitted
- 21 Oct 2013
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brosved M, Hirlekar G, Philip Wigh J, Sundberg H, Ziden L, Karlsson T, Albertsson P, Back M. Effects of Cardiac Rehabilitation on Physical Fitness, Physical Function, and Self-reported Outcomes in Patients >/=80 yr: A RANDOMIZED CONTROLLED TRIAL. J Cardiopulm Rehabil Prev. 2022 Sep 1;42(5):331-337. doi: 10.1097/HCR.0000000000000683. Epub 2022 Mar 31.
PubMed 35362694
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise in Patients With Coronary Artery Disease Aged 80 Years or Older - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02025257
- Acronym / sponsor ID
- 462-13
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, elderly, exercise, exercise-based cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- May 2019 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 1 Jan 2014 (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 purpose of this study is to investigate the effects of exercise for patients with coronary artery disease (CAD) aged 80 years and older, with special reference to maximum aerobic capacity, muscle endurance, physical functioning, level of physical activity, health related quality of life, anxiety, depression and endothelial function, compared to a control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseIndividually prescribed hospital based exercise in group two times a week, home-based exercise once a week. The exercise intervention consists of interval based aerobic exercise on a bicycle ergometer 30 minutes with intensity level at 13-17 at Borg scale, resistance exercises and balance exercises |
| Control | No intervention | –Patients are asked to live as usual. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of acute coronary artery disease
- Aged 80 years or older
Key exclusion criteria (3 listed)
- Inability to understand or speak the Swedish language
- Serious physical or psychological disease interfering with participation in an exercise intervention
- Patients are already exercising three times or more/week
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 |
|---|---|---|
| ExerciseIndividually prescribed hospital based exercise in group two times a week, home-based exercise once a week. The exercise intervention consists of interval based aerobic exercise on a bicycle ergometer 30 minutes with intensity level at 13-17 at Borg scale, resistance exercises and balance exercises | Other | Exercise |
Primary outcome
Change in maximum aerobic capacity
Time frame: At baseline and after 4 months
A maximum exercise test on an electronically braked cycle ergometer, with watts as marker of maximum aerobic capacity.
7 secondary outcomes
Change in level of physical activity
Time frame: At baseline and after 4 months
Change in muscular endurance
Time frame: At baseline and after 4 months
Change in physical functioning
Time frame: At baseline and after 4 months
Change in health related quality of life
Time frame: At baselline and after 4 months
Change in anxiety and depression
Time frame: At baseline and after 4 months
Change in endothelial function
Time frame: At baseline and after 4 months
Change in transthoracic evaluation of resting coronary flow velocity
Time frame: At baseline and after 4 months
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 15 Apr 2022.
- Results publication: PubMed 35362694Brosved M, Hirlekar G, Philip Wigh J, Sundberg H, Ziden L, Karlsson T, Albertsson P, Back M. Effects of Cardiac Rehabilitation on Physical Fitness, Physical Function, and Self-reported Outcomes in Patients >/=80 yr: A RANDOMIZED CONTROLLED TRIAL. J Cardiopulm Rehabil Prev. 2022 Sep 1;42(5):331-337. doi: 10.1097/HCR.0000000000000683. Epub 2022 Mar 31.
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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.
Maria Bäck, PhD principal investigator
Department of Physiotherapy, Sahlgrenska University Hospital, Gothenburg, Sweden
Per Albertsson, PhD study chair
Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden
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 Coronary Artery Disease, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 2 inclusion and 3 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 15 Apr 2022. 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 Sweden. 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?
Change in maximum aerobic capacity (time frame: At baseline and after 4 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 NCT02025257, which also lists 1 linked publication.
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 15 Apr 2022.