Frailty SyndromeNCT04768283
Cardiac Rehabilitation and Additional Physical Training in Elderly Patients After Acute Coronary Syndrome
A study testing Additional balance and resistance training - 1 and Additional balance and resistance training - 2 in people with Frailty Syndrome and Ischaemic Heart Disease, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
The aim of this study is to evaluate functional and physical capacity, health-related quality of life and associations with frailty in older patients after ischemic heart disease and interventional treatment with an individualized physical training program in the second phase of cardiac rehabilitation. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty Syndrome, Ischaemic Heart Disease
- What is being tested?
- Additional balance and resistance training - 1 and Additional balance and resistance training - 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteLithuania
- Study dates
- 6 Jan 2020to 30 Oct 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients after acute coronary syndrome and percutaneous coronary intervention or coronary bypass surgery;
- Age 65 years and older;
- 6-minute walk distance (6-MWD) ≥150 meters;
- Left ventricular ejection fraction ≥ 40%;
- Patient's agreement to participate in the study.
Who cannot join
- combined coronary artery bypass grafting and valve surgery;
- Cardiac devices;
- Diseases in the musculoskeletal system or other organs complicating physical activity and exercise training;
- Exercise-limiting comorbidities (primarily orthopedic and neurological conditions that would exclude individuals from participating in cardiac rehabilitation according to study protocol), cognitive or linguistic deficits.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
Kulautuva, Kaunas County
Aurelija Beigienė, MD, +37065875579, aurelija.beigiene@lsmuni.lt
Daiva Petruševičienė, PhD
About this study
Official title: Evaluation of Cardiac Rehabilitation Functional and Physical Capacity, Health-related Quality of Life and Associations With Frailty in Older Patients After Ischemic Heart Disease and Interventional Treatment
The aim of this study is to evaluate functional and physical capacity, health-related quality of life and associations with frailty in older patients after ischemic heart disease and interventional treatment with an individualized physical training program in the second phase of cardiac rehabilitation.
- Conditions
- Frailty Syndrome, Ischaemic Heart Disease
- Being tested
- Additional balance and resistance training - 1, Additional balance and resistance training - 2
- Keywords
- Frailty, Cardiac surgery, Cardiac rehabilitation, Exercise training, Resistance training, Balance training
- Medical subject headings
- Frailty, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional balance and resistance training - 1Other
Additional exercise program with balance and resistance training three times per week.
The balance training included exercises to improve static as well as dynamic balance ability, for 15-20 minutes.
The resistance training included exercises with weights (0,5, 1 or 2 kg), elastic resistance rubbers, intensity 30-50% 1-RM, 10 repetitions with 3 sets and 3 minute rest between sets.
Additional balance and resistance training - 2Other
Additional exercise program with balance and resistance training three times per week.
The balance training included exercises with static and dynamic balance training device Biodex Balance System TM SD, for 15-20 minutes. Exercises are performed with the following programs: Postural stability training, Limits of stability training, Weight shift training, Maze control training, Random control training, Percent weight-bearing training.
The resistance training included exercises with HUR strength training machines, intensity 30-50% 1-RM, 10 repetitions with 3 sets and 3 minute rest between sets. Strength training was performed with the following exercises: Leg press, leg extension, leg abduction, leg adduction.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Cardiac rehabilitation physical training program included: respiratory muscle training (7 days/week, for 15 minutes) and aerobic exercises on cycle ergometers (6 days/week, for 10-30 minutes, 30-50% watts or 30-50% HRmax). |
| Intervention group 1 | Experimental | Combinated physical training program:
Respiratory exercises, aerobic training will be the same as in the control group.
Additional exercises: balance training and strength exercises with weights, elastic resistance rubbers. Receives: Other: Additional balance and resistance training - 1 |
| Intervention group 2 | Experimental | Combinated physical training program:
Respiratory exercises, aerobic training will be the same as in the control group.
Additional exercises: balance training with static and dynamic balance training device Biodex Balance System TM SD and strength exercises with HUR strength training machines. Receives: Other: Additional balance and resistance training - 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty level by Edmonton frail scale score
Frailty measured by The Edmonton frail scale score - 0-3 - fit, 4-5 - vulnerable, 6-7 - mild frailty, 8-9 - moderate frailty,10-17 - severe frailty.
Measured: baseline
Change from baseline functional capacity by six minutes walking test (6MWT)
6MWT measured by meters
Measured: baseline, 3 weeks
Change from baseline cardiopulmonary exercise capacity by maximal load (maxWatt)
Maximal load measured with spiroergometry by maximal watts
Measured: baseline, 3 weeks
Change from baseline cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
Measured: baseline, 3 weeks
Change from baseline quality of life by MacNew questionnaire
The MacNew Heart Disease HRQL questionnaire consists of 27 items which fall into three domains (a 13-item physical limitations domain scale, a 14-item emotional function domain scale, and a 13-item social function domain scale). There are 5 items that inquire about symptoms: angina/chest pain, shortness of breath, fatigue, dizziness, and aching legs. The time frame for the MacNew is the previous two weeks.
Measured: baseline, 3 weeks
Secondary outcomes (2)
Change from baseline physical performance by Short Physical Performance Battery (SPPB)
The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests.The scores range from 0 (worst performance) to 12 (best performance).
Measured: baseline, 3 weeks
Change from baseline muscular strength by one repetition maximum test (1RM)
1RM test for leg extension measured by kilograms
Measured: baseline, 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start6 Jan 2020
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aurelija Beigienė, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768283
- Sponsor's protocol ID
- 2019-12-19 BE-2-107
- Status last verified
- Mar 2021
- First submitted
- 21 Feb 2021
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiac Rehabilitation Functional and Physical Capacity, Health-related Quality of Life and Associations With Frailty in Older Patients After Ischemic Heart Disease and Interventional Treatment
- ClinicalTrials.gov ID
- NCT04768283
- Acronym / sponsor ID
- 2019-12-19 BE-2-107
- Conditions
- Frailty Syndrome, Ischaemic Heart Disease
- Keywords
- Frailty, Cardiac surgery, Cardiac rehabilitation, Exercise training, Resistance training, Balance training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 24 Feb 2021 (actual)
- 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 evaluate functional and physical capacity, health-related quality of life and associations with frailty in older patients after ischemic heart disease and interventional treatment with an individualized physical training program in the second phase of cardiac rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Cardiac rehabilitation physical training program included: respiratory muscle training (7 days/week, for 15 minutes) and aerobic exercises on cycle ergometers (6 days/week, for 10-30 minutes, 30-50% watts or 30-50% HRmax). |
| Intervention group 1 | Experimental | Other: Additional balance and resistance training - 1Combinated physical training program: Respiratory exercises, aerobic training will be the same as in the control group. Additional exercises: balance training and strength exercises with weights, elastic resistance rubbers. |
| Intervention group 2 | Experimental | Other: Additional balance and resistance training - 2Combinated physical training program: Respiratory exercises, aerobic training will be the same as in the control group. Additional exercises: balance training with static and dynamic balance training device Biodex Balance System TM SD and strength exercises with HUR strength training machines. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients after acute coronary syndrome and percutaneous coronary intervention or coronary bypass surgery;
- Age 65 years and older;
- 6-minute walk distance (6-MWD) ≥150 meters;
- Left ventricular ejection fraction ≥ 40%;
- Patient's agreement to participate in the study.
Key exclusion criteria (4 listed)
- combined coronary artery bypass grafting and valve surgery;
- Cardiac devices;
- Diseases in the musculoskeletal system or other organs complicating physical activity and exercise training;
- Exercise-limiting comorbidities (primarily orthopedic and neurological conditions that would exclude individuals from participating in cardiac rehabilitation according to study protocol), cognitive or linguistic deficits.
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 |
|---|---|---|
| Additional balance and resistance training - 1Additional exercise program with balance and resistance training three times per week. The balance training included exercises to improve static as well as dynamic balance ability, for 15-20 minutes. The resistance training included exercises with weights (0,5, 1 or 2 kg), elastic resistance rubbers, intensity 30-50% 1-RM, 10 repetitions with 3 sets and 3 minute rest between sets. | Other | Intervention group 1 |
| Additional balance and resistance training - 2Additional exercise program with balance and resistance training three times per week. The balance training included exercises with static and dynamic balance training device Biodex Balance System TM SD, for 15-20 minutes. Exercises are performed with the following programs: Postural stability training, Limits of stability training, Weight shift training, Maze control training, Random control training, Percent weight-bearing training. The resistance training included exercises with HUR strength training machines, intensity 30-50% 1-RM, 10 repetitions with 3 sets and 3 minute rest between sets. Strength training was performed with the following exercises: Leg press, leg extension, leg abduction, leg adduction. | Other | Intervention group 2 |
Primary outcome
Frailty level by Edmonton frail scale score
Time frame: baseline
Frailty measured by The Edmonton frail scale score - 0-3 - fit, 4-5 - vulnerable, 6-7 - mild frailty, 8-9 - moderate frailty,10-17 - severe frailty.
Change from baseline functional capacity by six minutes walking test (6MWT)
Time frame: baseline, 3 weeks
6MWT measured by meters
Change from baseline cardiopulmonary exercise capacity by maximal load (maxWatt)
Time frame: baseline, 3 weeks
Maximal load measured with spiroergometry by maximal watts
Change from baseline cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
Time frame: baseline, 3 weeks
PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
Change from baseline quality of life by MacNew questionnaire
Time frame: baseline, 3 weeks
The MacNew Heart Disease HRQL questionnaire consists of 27 items which fall into three domains (a 13-item physical limitations domain scale, a 14-item emotional function domain scale, and a 13-item social function domain scale). There are 5 items that inquire about symptoms: angina/chest pain, shortness of breath, fatigue, dizziness, and aching legs. The time frame for the MacNew is the previous two weeks.
2 secondary outcomes
Change from baseline physical performance by Short Physical Performance Battery (SPPB)
Time frame: baseline, 3 weeks
Change from baseline muscular strength by one repetition maximum test (1RM)
Time frame: baseline, 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional balance and resistance training - 1 and Additional balance and resistance training - 2 in people with Frailty Syndrome and Ischaemic Heart Disease, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Mar 2021. 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 Lithuania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurelija Beigienė, MD (+37065875579, aurelija.beigiene@kaunoklinikos.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty level by Edmonton frail scale score (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2021.