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Completed

NCT Number: NCT04234087

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

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.

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Key information

Conditions

Frailty Syndrome Cardiovascular Diseases Frailty Heart Diseases Heart Valve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Valve Heart Disease

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva

Kaunas, Kulautuva, Lithuania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Additional balance and resistance training

Other

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.

Primary outcomes

  1. Physical performance by Short Physical Perfromance Battery (SPPB)

    Time frame: Baseline

    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).

  2. Physical performance by Short Physical Perfromance Battery (SPPB)

    Time frame: 20 days

    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).

  3. Physical performance by Short Physical Perfromance Battery (SPPB)

    Time frame: Three months

    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).

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

    Time frame: Baseline

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

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

    Time frame: 20 days

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

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

    Time frame: 3 months

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

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

    Time frame: Baseline

    6MWT measured by meters

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

    Time frame: 20 days

    6MWT measured by meters

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

    Time frame: 3 months

    6MWT measured by meters

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

    Time frame: Baseline

    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

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

    Time frame: 20 days

    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

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

    Time frame: 3 months

    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

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

    Time frame: Baseline

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

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

    Time frame: 20 days

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

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

    Time frame: 3 months

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

  16. Quality of life by questionnaire EQ-5D

    Time frame: Baseline

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

  17. Quality of life by questionnaire EQ-5D

    Time frame: 20 days

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

  18. Quality of life by questionnaire EQ-5D

    Time frame: 3 months

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

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

    Time frame: Baseline

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

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

    Time frame: 20 days

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

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

    Time frame: 3 months

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

Secondary outcomes

  1. Frailty level by SPPB score

    Time frame: baseline

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

  2. Frailty level by SPPB score

    Time frame: 20 days

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

  3. Frailty level by SPPB score

    Time frame: three months

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

  4. Frailty level by 5MWT

    Time frame: baseline

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

  5. Frailty level by 5MWT

    Time frame: 20 days

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

  6. Frailty level by 5MWT

    Time frame: three months

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

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

    Time frame: 3 months

    IPAQ in units on the scale

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

    Time frame: 20 days

    IPAQ in units on the scale

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

    Time frame: Baseline

    IPAQ in units on the scale

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

    Time frame: Baseline

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

  11. Cardiopulmonary exercise capacity by maximal load (maxWatt)

    Time frame: Baseline

    Maximal load measured with spiroergometry by maximal watts

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

    Time frame: 20 days

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

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

    Time frame: 3 months

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

  14. Cardiopulmonary exercise capacity by maximal load (maxWatt)

    Time frame: 20 days

    Maximal load measured with spiroergometry by maximal watts

  15. Cardiopulmonary exercise capacity by maximal load (maxWatt)

    Time frame: 3 months

    Maximal load measured with spiroergometry by maximal watts

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

    Time frame: baseline

    1RM test for leg extension measured by kilograms

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

    Time frame: 20 days

    1RM test for leg extension measured by kilograms

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

    Time frame: 3 months

    1RM test for leg extension measured by kilograms

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 21, 2020
Registry last updated
Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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