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Frailty SyndromeNCT04234087

Feasibility and Effectiveness of an Additional Resistance and Balance Training in Cardiac Rehabilitation of Older Patients After Valve Surgery or Intervention

A study testing Additional balance and resistance training in people with Frailty Syndrome and Quality of Life, run by Lithuanian University of Health Sciences at 1 site in Lithuania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to evaluate the short- and medium-term effectiveness of additional moderate dynamic resistance and balance training to the CR-program of old adults after valve surgery or intervention compared to usual care-CR. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Additional balance and resistance training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteLithuania
Study dates
26 Feb 2018to 30 Jun 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
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patients after valve surgery and/or intervention
  • Age 65 years and older
  • Ability to start CR within 4 weeks after surgery,
  • 6-minute walk distance (6-MWD) ≥100- ≤350 m (1)
  • Patient's agreement to participate in the study.

Who cannot join

  • 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 CR according to study protocol), including chronic heart failure New York Heart Association Class IV, hemoglobin less than 9 g/dL, wound healing disturbance, cognitive or linguistic deficits.

Trial locations and contacts

1 site in 1 country.

Lithuania1 site
  • LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva

    Kaunas, Kulautuva

Other trials in Lithuania

About this study

The aim of the study is to evaluate the short- and medium-term effectiveness of additional moderate dynamic resistance and balance training to the CR-program of old adults after valve surgery or intervention compared to usual care-CR.

Being tested
Additional balance and resistance training
Keywords
Cardiac rehabilitation, Exercise training, Resistance training, Balance training, Physical capacity, Valve surgery, Valve intervention, Functional capacity
Medical subject headings
Frailty, Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Additional balance and resistance trainingOther

    Additional exercise program with balance and resistance training three times per week. After completion participants are encouraged to continue exercise training at home according to recommendations and will receive control calls every two weeks.

Study groups in NCT04234087
Study groupRoleWhat they receive
Control groupNo interventionThe supervised exercise program included: continues endurance training on cycle ergometers (6 sessions a week). Every session included warm up (<50% target intensity 2 min, gradually increasing load 1-10 w/min up to target intensity within 5 - 10 min); exercise phase (100% of the target intensity (30-50% watts or 30-50% HRmax), starting with >5 minutes and gradually prolonged up to 30 min); cool down with gradual reduction of the load within 3 minutes); additional aerobic exercises performed sitting and/or standing (30 minutes, 5 days/week); respiratory muscle training (7 days/week, for 15 minutes) using ball trainer.
Intervention groupOtherExercise program as for a control group together with additional resistance and balance training 3 sessions/week. The resistance training was started with low intensity (<30% 1-RM, RPE ≤ 11, 5-10 repetitions), increased gradually to moderate intensity (30-50% and up to 60% 1-RM, RPE 12-13, after 8-15 repetitions) with 3 sets and 3 minute rest between sets, if tolerated. The balance training included exercises to improve static as well as dynamic balance ability. It was performed on 2-3 days/week for 10-15 minutes. The complexity of the balance exercises was selected and incremented individually by changing the stand-position, the base on which the stands were performed and/or using unstable surfaces. If tolerated, the visual information was varied and/or additional tasks performed while balancing. After completion participants were encouraged to continue exercise training at home according to recommendations.
Receives: Other: Additional balance and resistance training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical performance by Short Physical Perfromance 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

  2. Physical performance by Short Physical Perfromance 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: 20 days

  3. Physical performance by Short Physical Perfromance 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: Three months

  4. Physical performance by 5 meters walking test (5MWT)

    5MWT is a gate speed test measured by meters per second.

    Measured: Baseline

  5. Physical performance by 5 meters walking test (5MWT)

    5MWT is a gate speed test measured by meters per second.

    Measured: 20 days

  6. Physical performance by 5 meters walking test (5MWT)

    5MWT is a gate speed test measured by meters per second.

    Measured: 3 months

  7. Functional capacity by six minutes walking test (6MWT)

    6MWT measured by meters

    Measured: Baseline

  8. Functional capacity by six minutes walking test (6MWT)

    6MWT measured by meters

    Measured: 20 days

  9. Functional capacity by six minutes walking test (6MWT)

    6MWT measured by meters

    Measured: 3 months

  10. Quality of life by questionnaire Short Form Survey SF-36

    0-100%, the higher score, the better quality of life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH) in units on the scale

    Measured: Baseline

  11. Quality of life by questionnaire Short Form Survey SF-36

    0-100%, the higher score, the better quality of life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH) in units on the scale

    Measured: 20 days

  12. Quality of life by questionnaire Short Form Survey SF-36

    0-100%, the higher score, the better quality of life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH) in units on the scale

    Measured: 3 months

  13. Quality of life by questionnaire Minnesota living with heart failure (Minesota HF)

    Minesota HF questionnaire in units on the scale, 0-105, the the lower score, the better quality of life

    Measured: Baseline

  14. Quality of life by questionnaire Minnesota living with heart failure (Minesota HF)

    Minesota HF questionnaire in units on the scale, 0-105, the the lower score, the better quality of life

    Measured: 20 days

  15. Quality of life by questionnaire Minnesota living with heart failure (Minesota HF)

    Minesota HF questionnaire in units on the scale, 0-105, the the lower score, the better quality of life

    Measured: 3 months

  16. Quality of life by questionnaire EQ-5D

    EQ-5D in units on the scale, 0-10, the higher score, the better quality of life

    Measured: Baseline

  17. Quality of life by questionnaire EQ-5D

    EQ-5D in units on the scale, 0-10, the higher score, the better quality of life

    Measured: 20 days

  18. Quality of life by questionnaire EQ-5D

    EQ-5D in units on the scale, 0-10, the higher score, the better quality of life

    Measured: 3 months

  19. Quality of life by questionnaire Quality of Life: Cardiac Index

    Quality of Life: Cardiac Index in units on the scale, 15-33 the higher score, the better quality of life

    Measured: Baseline

  20. Quality of life by questionnaire Quality of Life: Cardiac Index

    Quality of Life: Cardiac Index in units on the scale, 15-33 the higher score, the better quality of life

    Measured: 20 days

  21. Quality of life by questionnaire Quality of Life: Cardiac Index

    Quality of Life: Cardiac Index in units on the scale, 15-33 the higher score, the better quality of life

    Measured: 3 months

Secondary outcomes (18)
  1. Frailty level by SPPB score

    Frailty measured by SPPB score - 0-7 - frail, 8-9 - pre-frail, 10-12 robust.

    Measured: baseline

  2. Frailty level by SPPB score

    Frailty measured by SPPB score - 0-7 - frail, 8-9 - pre-frail, 10-12 robust.

    Measured: 20 days

  3. Frailty level by SPPB score

    Frailty measured by SPPB score - 0-7 - frail, 8-9 - pre-frail, 10-12 robust.

    Measured: three months

  4. Frailty level by 5MWT

    Frailty measured by 5MWT - <0,6 m/s - frail, 0,7-0,99 m/s - pre-frail, 1,0 m/s and more - robust

    Measured: baseline

  5. Frailty level by 5MWT

    Frailty measured by 5MWT - <0,6 m/s - frail, 0,7-0,99 m/s - pre-frail, 1,0 m/s and more - robust

    Measured: 20 days

  6. Frailty level by 5MWT

    Frailty measured by 5MWT - <0,6 m/s - frail, 0,7-0,99 m/s - pre-frail, 1,0 m/s and more - robust

    Measured: three months

  7. Physical activity by International physical activity questionnaire (IPAQ)

    IPAQ in units on the scale

    Measured: 3 months

  8. Physical activity by International physical activity questionnaire (IPAQ)

    IPAQ in units on the scale

    Measured: 20 days

  9. Physical activity by International physical activity questionnaire (IPAQ)

    IPAQ in units on the scale

    Measured: Baseline

  10. 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

  11. Cardiopulmonary exercise capacity by maximal load (maxWatt)

    Maximal load measured with spiroergometry by maximal watts

    Measured: Baseline

  12. Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)

    PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute

    Measured: 20 days

  13. Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)

    PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute

    Measured: 3 months

  14. Cardiopulmonary exercise capacity by maximal load (maxWatt)

    Maximal load measured with spiroergometry by maximal watts

    Measured: 20 days

  15. Cardiopulmonary exercise capacity by maximal load (maxWatt)

    Maximal load measured with spiroergometry by maximal watts

    Measured: 3 months

  16. Muscular strength by one repetition maximum test (1RM)

    1RM test for leg extension measured by kilograms

    Measured: baseline

  17. Muscular strength by one repetition maximum test (1RM)

    1RM test for leg extension measured by kilograms

    Measured: 20 days

  18. Muscular strength by one repetition maximum test (1RM)

    1RM test for leg extension measured by kilograms

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2020
  2. Study start26 Feb 2018
  3. Primary completion1 Feb 2020
  4. Study completion30 Jun 2020

Resources

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
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04234087
Sponsor's protocol ID
LUHS001
Status last verified
Jul 2020
First submitted
12 Jan 2020
Last updated
16 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tamuleviciute-Prasciene E, Beigiene A, Thompson MJ, Balne K, Kubilius R, Bjarnason-Wehrens B. The impact of additional resistance and balance training in exercise-based cardiac rehabilitation in older patients after valve surgery or intervention: randomized control trial. BMC Geriatr. 2021 Jan 7;21(1):23. doi: 10.1186/s12877-020-01964-3.

    PubMed 33413144

Questions about this trial

What is this clinical trial studying?

A study testing Additional balance and resistance training in people with Frailty Syndrome and Quality of Life, 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 2 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 16 Jul 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 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?

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?

Physical performance by Short Physical Perfromance Battery (SPPB) (time frame: Baseline). The study lists 21 primary outcomes in all. 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 NCT04234087, 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 16 Jul 2020.

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