search
Back to results

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

Primary Purpose

Frailty Syndrome, Quality of Life, Valve Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Additional balance and resistance training
Sponsored by
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty Syndrome focused on measuring Cardiac rehabilitation, Exercise training, Resistance training, Balance training, Physical capacity, Valve surgery, Valve intervention, Functional capacity

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Control group

Intervention group

Arm Description

The 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.

Exercise 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.

Outcomes

Primary Outcome Measures

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).
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).
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).
Physical performance by 5 meters walking test (5MWT)
5MWT is a gate speed test measured by meters per second.
Physical performance by 5 meters walking test (5MWT)
5MWT is a gate speed test measured by meters per second.
Physical performance by 5 meters walking test (5MWT)
5MWT is a gate speed test measured by meters per second.
Functional capacity by six minutes walking test (6MWT)
6MWT measured by meters
Functional capacity by six minutes walking test (6MWT)
6MWT measured by meters
Functional capacity by six minutes walking test (6MWT)
6MWT measured by meters
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
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
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
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
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
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
Quality of life by questionnaire EQ-5D
EQ-5D in units on the scale, 0-10, the higher score, the better quality of life
Quality of life by questionnaire EQ-5D
EQ-5D in units on the scale, 0-10, the higher score, the better quality of life
Quality of life by questionnaire EQ-5D
EQ-5D in units on the scale, 0-10, the higher score, the better quality of life
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
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
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

Secondary Outcome Measures

Frailty level by SPPB score
Frailty measured by SPPB score - 0-7 - frail, 8-9 - pre-frail, 10-12 robust.
Frailty level by SPPB score
Frailty measured by SPPB score - 0-7 - frail, 8-9 - pre-frail, 10-12 robust.
Frailty level by SPPB score
Frailty measured by SPPB score - 0-7 - frail, 8-9 - pre-frail, 10-12 robust.
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
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
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
Physical activity by International physical activity questionnaire (IPAQ)
IPAQ in units on the scale
Physical activity by International physical activity questionnaire (IPAQ)
IPAQ in units on the scale
Physical activity by International physical activity questionnaire (IPAQ)
IPAQ in units on the scale
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
Cardiopulmonary exercise capacity by maximal load (maxWatt)
Maximal load measured with spiroergometry by maximal watts
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
Cardiopulmonary exercise capacity by maximal load (maxWatt)
Maximal load measured with spiroergometry by maximal watts
Cardiopulmonary exercise capacity by maximal load (maxWatt)
Maximal load measured with spiroergometry by maximal watts
Muscular strength by one repetition maximum test (1RM)
1RM test for leg extension measured by kilograms
Muscular strength by one repetition maximum test (1RM)
1RM test for leg extension measured by kilograms
Muscular strength by one repetition maximum test (1RM)
1RM test for leg extension measured by kilograms

Full Information

First Posted
January 12, 2020
Last Updated
July 14, 2020
Sponsor
Lithuanian University of Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT04234087
Brief Title
Feasibility and Effectiveness of an Additional Resistance and Balance Training in Cardiac Rehabilitation of Older Patients After Valve Surgery or Intervention
Official Title
Feasibility and Effectiveness of an Additional Resistance and Balance Training in Cardiac Rehabilitation of Older Patients After Valve Surgery or Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty Syndrome, Quality of Life, Valve Heart Disease
Keywords
Cardiac rehabilitation, Exercise training, Resistance training, Balance training, Physical capacity, Valve surgery, Valve intervention, Functional capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
The 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.
Arm Title
Intervention group
Arm Type
Other
Arm Description
Exercise 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.
Intervention Type
Other
Intervention Name(s)
Additional balance and resistance training
Intervention Description
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 Outcome Measure Information:
Title
Physical performance by Short Physical Perfromance Battery (SPPB)
Description
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).
Time Frame
Baseline
Title
Physical performance by Short Physical Perfromance Battery (SPPB)
Description
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).
Time Frame
20 days
Title
Physical performance by Short Physical Perfromance Battery (SPPB)
Description
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).
Time Frame
Three months
Title
Physical performance by 5 meters walking test (5MWT)
Description
5MWT is a gate speed test measured by meters per second.
Time Frame
Baseline
Title
Physical performance by 5 meters walking test (5MWT)
Description
5MWT is a gate speed test measured by meters per second.
Time Frame
20 days
Title
Physical performance by 5 meters walking test (5MWT)
Description
5MWT is a gate speed test measured by meters per second.
Time Frame
3 months
Title
Functional capacity by six minutes walking test (6MWT)
Description
6MWT measured by meters
Time Frame
Baseline
Title
Functional capacity by six minutes walking test (6MWT)
Description
6MWT measured by meters
Time Frame
20 days
Title
Functional capacity by six minutes walking test (6MWT)
Description
6MWT measured by meters
Time Frame
3 months
Title
Quality of life by questionnaire Short Form Survey SF-36
Description
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
Time Frame
Baseline
Title
Quality of life by questionnaire Short Form Survey SF-36
Description
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
Time Frame
20 days
Title
Quality of life by questionnaire Short Form Survey SF-36
Description
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
Time Frame
3 months
Title
Quality of life by questionnaire Minnesota living with heart failure (Minesota HF)
Description
Minesota HF questionnaire in units on the scale, 0-105, the the lower score, the better quality of life
Time Frame
Baseline
Title
Quality of life by questionnaire Minnesota living with heart failure (Minesota HF)
Description
Minesota HF questionnaire in units on the scale, 0-105, the the lower score, the better quality of life
Time Frame
20 days
Title
Quality of life by questionnaire Minnesota living with heart failure (Minesota HF)
Description
Minesota HF questionnaire in units on the scale, 0-105, the the lower score, the better quality of life
Time Frame
3 months
Title
Quality of life by questionnaire EQ-5D
Description
EQ-5D in units on the scale, 0-10, the higher score, the better quality of life
Time Frame
Baseline
Title
Quality of life by questionnaire EQ-5D
Description
EQ-5D in units on the scale, 0-10, the higher score, the better quality of life
Time Frame
20 days
Title
Quality of life by questionnaire EQ-5D
Description
EQ-5D in units on the scale, 0-10, the higher score, the better quality of life
Time Frame
3 months
Title
Quality of life by questionnaire Quality of Life: Cardiac Index
Description
Quality of Life: Cardiac Index in units on the scale, 15-33 the higher score, the better quality of life
Time Frame
Baseline
Title
Quality of life by questionnaire Quality of Life: Cardiac Index
Description
Quality of Life: Cardiac Index in units on the scale, 15-33 the higher score, the better quality of life
Time Frame
20 days
Title
Quality of life by questionnaire Quality of Life: Cardiac Index
Description
Quality of Life: Cardiac Index in units on the scale, 15-33 the higher score, the better quality of life
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Frailty level by SPPB score
Description
Frailty measured by SPPB score - 0-7 - frail, 8-9 - pre-frail, 10-12 robust.
Time Frame
baseline
Title
Frailty level by SPPB score
Description
Frailty measured by SPPB score - 0-7 - frail, 8-9 - pre-frail, 10-12 robust.
Time Frame
20 days
Title
Frailty level by SPPB score
Description
Frailty measured by SPPB score - 0-7 - frail, 8-9 - pre-frail, 10-12 robust.
Time Frame
three months
Title
Frailty level by 5MWT
Description
Frailty measured by 5MWT - <0,6 m/s - frail, 0,7-0,99 m/s - pre-frail, 1,0 m/s and more - robust
Time Frame
baseline
Title
Frailty level by 5MWT
Description
Frailty measured by 5MWT - <0,6 m/s - frail, 0,7-0,99 m/s - pre-frail, 1,0 m/s and more - robust
Time Frame
20 days
Title
Frailty level by 5MWT
Description
Frailty measured by 5MWT - <0,6 m/s - frail, 0,7-0,99 m/s - pre-frail, 1,0 m/s and more - robust
Time Frame
three months
Title
Physical activity by International physical activity questionnaire (IPAQ)
Description
IPAQ in units on the scale
Time Frame
3 months
Title
Physical activity by International physical activity questionnaire (IPAQ)
Description
IPAQ in units on the scale
Time Frame
20 days
Title
Physical activity by International physical activity questionnaire (IPAQ)
Description
IPAQ in units on the scale
Time Frame
Baseline
Title
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
Description
PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
Time Frame
Baseline
Title
Cardiopulmonary exercise capacity by maximal load (maxWatt)
Description
Maximal load measured with spiroergometry by maximal watts
Time Frame
Baseline
Title
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
Description
PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
Time Frame
20 days
Title
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
Description
PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
Time Frame
3 months
Title
Cardiopulmonary exercise capacity by maximal load (maxWatt)
Description
Maximal load measured with spiroergometry by maximal watts
Time Frame
20 days
Title
Cardiopulmonary exercise capacity by maximal load (maxWatt)
Description
Maximal load measured with spiroergometry by maximal watts
Time Frame
3 months
Title
Muscular strength by one repetition maximum test (1RM)
Description
1RM test for leg extension measured by kilograms
Time Frame
baseline
Title
Muscular strength by one repetition maximum test (1RM)
Description
1RM test for leg extension measured by kilograms
Time Frame
20 days
Title
Muscular strength by one repetition maximum test (1RM)
Description
1RM test for leg extension measured by kilograms
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raimondas Kubilius, Prof
Organizational Affiliation
Lithuanian University of Health Sciences, Department of Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
City
Kaunas
State/Province
Kulautuva
Country
Lithuania

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33413144
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs