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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04234087
• Other study ID #: LUHS001
• Status: Completed
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: June 30, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frailty
• Frailty Syndrome
• Heart Diseases
• Heart Valve Diseases
• Quality of Life
• Valve Heart Disease

Intervention

Other:
• Additional balance and resistance training
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.

Locations

Country	Name	City	State
Lithuania	LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva	Kaunas	Kulautuva

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline
Primary	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).	20 days
Primary	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).	Three months
Primary	Physical performance by 5 meters walking test (5MWT)	5MWT is a gate speed test measured by meters per second.	Baseline
Primary	Physical performance by 5 meters walking test (5MWT)	5MWT is a gate speed test measured by meters per second.	20 days
Primary	Physical performance by 5 meters walking test (5MWT)	5MWT is a gate speed test measured by meters per second.	3 months
Primary	Functional capacity by six minutes walking test (6MWT)	6MWT measured by meters	Baseline
Primary	Functional capacity by six minutes walking test (6MWT)	6MWT measured by meters	20 days
Primary	Functional capacity by six minutes walking test (6MWT)	6MWT measured by meters	3 months
Primary	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	Baseline
Primary	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	20 days
Primary	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	3 months
Primary	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	Baseline
Primary	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	20 days
Primary	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	3 months
Primary	Quality of life by questionnaire EQ-5D	EQ-5D in units on the scale, 0-10, the higher score, the better quality of life	Baseline
Primary	Quality of life by questionnaire EQ-5D	EQ-5D in units on the scale, 0-10, the higher score, the better quality of life	20 days
Primary	Quality of life by questionnaire EQ-5D	EQ-5D in units on the scale, 0-10, the higher score, the better quality of life	3 months
Primary	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	Baseline
Primary	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	20 days
Primary	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	3 months
Secondary	Frailty level by SPPB score	Frailty measured by SPPB score - 0-7 - frail, 8-9 - pre-frail, 10-12 robust.	baseline
Secondary	Frailty level by SPPB score	Frailty measured by SPPB score - 0-7 - frail, 8-9 - pre-frail, 10-12 robust.	20 days
Secondary	Frailty level by SPPB score	Frailty measured by SPPB score - 0-7 - frail, 8-9 - pre-frail, 10-12 robust.	three months
Secondary	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	baseline
Secondary	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	20 days
Secondary	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	three months
Secondary	Physical activity by International physical activity questionnaire (IPAQ)	IPAQ in units on the scale	3 months
Secondary	Physical activity by International physical activity questionnaire (IPAQ)	IPAQ in units on the scale	20 days
Secondary	Physical activity by International physical activity questionnaire (IPAQ)	IPAQ in units on the scale	Baseline
Secondary	Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)	PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute	Baseline
Secondary	Cardiopulmonary exercise capacity by maximal load (maxWatt)	Maximal load measured with spiroergometry by maximal watts	Baseline
Secondary	Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)	PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute	20 days
Secondary	Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)	PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute	3 months
Secondary	Cardiopulmonary exercise capacity by maximal load (maxWatt)	Maximal load measured with spiroergometry by maximal watts	20 days
Secondary	Cardiopulmonary exercise capacity by maximal load (maxWatt)	Maximal load measured with spiroergometry by maximal watts	3 months
Secondary	Muscular strength by one repetition maximum test (1RM)	1RM test for leg extension measured by kilograms	baseline
Secondary	Muscular strength by one repetition maximum test (1RM)	1RM test for leg extension measured by kilograms	20 days
Secondary	Muscular strength by one repetition maximum test (1RM)	1RM test for leg extension measured by kilograms	3 months