Heart-Assist DevicesPREHAB-HFNCT03580759
Exergaming in Advanced HF With Multiple Chronic Conditions Prior to LVAD Implantation or Heart Transplant
A study testing PREHAB in people with Heart-Assist Devices and Heart Failure NYHA Class IV, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study is to test a home-based exergaming intervention designed to decrease frailty and fatigue and improve affective well-being, functional capacity, and immune function in individuals with advanced heart failure (HF) and multiple chronic conditions (MCC) prior to receiving either a left… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart-Assist Devices, Heart Failure NYHA Class IV, Exercise Training
- What is being tested?
- PREHAB
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 1 Mar 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >19 years
- diagnosis of advanced HF and a minimum of one additional co-occurring chronic condition
- undergoing evaluation for left ventricular assist device implantation or heart transplant
- medical clearance from a heart failure cardiologist in the Nebraska Medicine Advanced HF Clinic.
- the ability to speak and understand English
- age>19 years
- the ability to speak and understand English
Who cannot join
- cognitive impairment (Montreal Objective Cognitive Assessment39 [MoCA] < 26), -neuromuscular or orthopedic impairment that would preclude low-intensity physical activity
- unwillingness to complete two supervised sessions in the clinical setting, and one in the home setting
- ongoing inotrope therapy. (Exercise is discouraged during inotrope therapy.)
- inability to pass a Wii Fit Balance Board safety screen (prior to randomization in Phase 2)
- Unwillingness to participate in the supervised exergaming training sessions
- Unwillingness to participate in final qualitative interview
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: A Home-based Pre-Surgical Exergaming Intervention for Individuals With Advanced HF and Multiple Chronic Conditions Prior to Left Ventricular Assist Device Implantation or Heart Transplant
The purpose of this study is to test a home-based exergaming intervention designed to decrease frailty and fatigue and improve affective well-being, functional capacity, and immune function in individuals with advanced heart failure (HF) and multiple chronic conditions (MCC) prior to receiving either a left ventricular assist device (LVAD) or orthotopic heart transplantation (OHT). Prior to surgery, individuals with advanced HF/MCC experience a high symptom burden that often precludes them from participating in meaningful physical activity. Pre-surgical fitness programs have been used in other critically ill populations to improve function prior to surgery. Interactive gaming systems have been successfully used to engage other seriously ill adults in low-intensity physical activity. However, exergaming interventions have not yet been applied in individuals with advanced HF/MCC as prehabilitation prior to LVAD implantation or OHT. The investigators propose that a prehabilitation exergaming intervention will not only enhance pre-surgical outcomes but will also augment postoperative outcomes. This study is designed in two-phases. Phase 1 examines intervention feasibility and phase 2 is a pilot study with a two-group design. In phase 2, participants will be randomized to a usual care group or the exergaming intervention group. The exergaming group will participate in a low-intensity exergaming intervention and additional investigator-developed educational modules that will be delivered via the Nintendo Wii U exergaming system. The investigators will evaluate pre- and post-surgical frailty, fatigue, affective well-being, and immune function as primary outcomes. The investigators expect that participation in low intensity exergaming will improve these primary outcomes pre- and post-surgically, and decrease post-surgical complications and health care utilization. Investigator-developed modules will promote self-efficacy, self-regulation, and activation. This is the first study to apply low-intensity exergaming to a pre-operative advanced HF/MCC population. The successful application of this intervention has significant implications to the pre-operative conditioning of individuals with advanced HF/MCC prior to LVAD implantation or OHT.
Read the detailed description
Specific Aims. The objectives of this study are two-fold: (1) To test the feasibility of a low intensity, home-based exergaming intervention in individuals with advanced HF/MCC prior to left ventricular assist device (LVAD) implantation or orthotopic heart transplantation (OHT), and (2) To examine the effectiveness of delivering a low intensity, home-based exergaming intervention to decrease frailty and fatigue and improve affective well-being, functional capacity, and immune function in individuals with advanced HF/MCC prior to receiving an LVAD or OHT.
Other surgical populations who were deconditioned, fatigued, and frail before surgery have benefited from the use of pre-surgical fitness interventions (prehabilitation).3-5 Innovative interventions strategies, like the Nintendo Wii Fit exergaming system, have been successful at engaging seriously ill adults in low-intensity physical activity6,7. However, exergaming interventions have not yet been applied in individuals with advanced HF as prehabilitation prior to LVAD implantation or OHT. The investigators propose that a home-based, prehabilitation exergaming intervention will not only enhance pre-surgical outcomes but will also augment postoperative outcomes.
The investigators will conduct this study in two phases. Phase 1 is designed as a feasibility study in a smaller sample (5 participants and 5 informal caregivers) to allow initial evaluation of the intervention including troubleshooting the technological components and evaluating study recruitment, retention, and intervention safety prior to initiating the larger, two-group randomized study. Phase 2 will enroll a convenience sample of 40 participants with advanced HF/MCC who are being evaluated for LVAD implantation or OHT at Nebraska Medicine and their 40 informal caregivers for a total sample of 80 enrollees (n=40 exergaming, n=40 usual care).
In both phases, the exergaming group will participate in a low-intensity exergaming intervention and additional investigator-developed educational modules (e.g. symptoms while exercising, exercising with heart failure) that will be delivered via the Nintendo Wii U exergaming system. Investigator-developed modules are designed to promote self-efficacy, self-regulation, and activation. Individuals with advanced HF/MCC will be expected to participate in the exergaming intervention and the investigator-developed modules. Caregivers will be asked to be present for all training sessions and participate in the investigator-developed modules. The investigators will evaluate pre- and post-surgical frailty, fatigue, affective well-being, and immune function as primary outcomes in the individuals with advanced HF/MCC. The investigators expect that participation in low intensity exergaming will improve these primary outcomes pre- and post-surgically, and decrease post-surgical complications and health care utilization. Relationships will be examined among self-efficacy, self-regulation, and activation scores over time, and adherence to the intervention to test whether self-management mechanisms were effective in promoting adherence. Additionally, post-intervention qualitative interviews will be conducted to assess participant and caregiver experiences with the intervention.
Specific aims of this study are the following:
Aim 1 (Phase 1): Evaluate the feasibility of the home-based, low intensity exergaming intervention in individuals with advanced HF/MCC prior to LVAD implantation or OHT and their informal caregivers by assessing recruitment, enrollment, acceptability, adherence, subjects perception of barriers and facilitators, and implementation (delivery, fidelity, and procedures for data collection).
Aim 2 (Phase 2): Evaluate the impact of home-based, low intensity exergaming on pre- and post-surgical outcomes: frailty, fatigue, affective well-being, immune function, and biomarkers of co-morbid conditions at baseline, 4 weeks, and 1 and 3 months post-surgery compared to usual care (All subjects with advanced HF/MCC).
H1. Subjects in the exergaming group will have decreased frailty and fatigue and improved affective well-being and immune function compared to usual care.
Aim 3 (Phase 2): Evaluate the impact of home-based, low intensity exergaming on post-surgical complications (death, infection, bleeding, and rejection) and health care utilization (emergency department visits, unplanned hospital admissions) compared to usual care (both groups of subjects).
H2.a. Subjects in the exergaming group will have fewer post-surgical complications compared to usual care.
H2.b. Subjects in the exergaming group will have fewer emergency department visits and hospital admissions compared to usual care.
Aim 4 (Phase 2): Explore relationships among self-efficacy, self-regulation, and activation scores over time, intervention adherence, and pre- and post-surgical outcomes (Exergaming group participants and caregivers only).
There is a critical need to address deconditioning, fatigue, and frailty in individuals with advanced HF/MCC prior to LVAD implantation or OHT. This innovative exergaming intervention incorporates the use of an interactive, home-based technology to improve pre-and post-surgical outcomes
- Being tested
- PREHAB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREHABBehavioural
After three supervised training sessions, subjects will be asked to participate in a daily exergaming activity tailored to their physical activity capabilities and needs. Subjects will be taught to rate their perceived exertion and monitor their target heart rate using a Fit Bit Charge HR. Daily exercise diaries will be used to monitor subject-perceived progress throughout the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Exergaming | Experimental | Subjects in the exergaming group will participate in three exergaming training sessions with the Wii Fit U exergaming system. The Wii Fit U will then be left in the subjects' homes for a minimum of four weeks prior to left ventricular assist device implantation or heart transplant. Receives: Behavioral: PREHAB |
| Usual Care | No intervention | Subjects in the usual care group will be encouraged to partake in physical activity as recommended in the 2017 AHA/ACC/HFSA guidelines for heart failure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Capacity from Baseline
Functional capacity will be assessed with a six-minute walk test. Subjects will be asked to walk for 6 min to determine what distance they can accomplish in that time period at a normal walking pace.
Measured: Baseline, 1 month post-intervention, 1 & 3 months post-surgery
Change in Physical Frailty from Baseline
Physical frailty will be assessed using the Fried criteria which include: Unintentional weight loss (10 lbs in past year), exhaustion, weakness (grip strength), slow walking speed, and low physical activity (0 criteria-not frail; 1-2 criteria-pre-frail; ≥3-frail)
Measured: Baseline, 1 month post-intervention, 1 & 3 months post-surgery
Change in Fatigue from Baseline
Fatigue will be assessed with the NINR Fatigue Common Data Element which is a 6-item self-report 5-item Likert scale. Higher scores indicate greater feelings of fatigue. Max score is 30.
Measured: Baseline, 1 month post-intervention, 1 & 3 months post-surgery
Secondary outcomes (1)
Change in Immune Function from Baseline
Immune function will be assessed with a cell-mediated immune function assay (ImmuKnow) that is commercially available.
Measured: Baseline, 1 month post-intervention, 1 & 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start1 Mar 2019
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart-Assist DevicesStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Windy W Alonso, PhD, RN, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580759
- Sponsor's protocol ID
- 0407-18-FB
- Acronym
- PREHAB-HF
- Status last verified
- Sep 2023
- First submitted
- 13 Jun 2018
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Home-based Pre-Surgical Exergaming Intervention for Individuals With Advanced HF and Multiple Chronic Conditions Prior to Left Ventricular Assist Device Implantation or Heart Transplant
- ClinicalTrials.gov ID
- NCT03580759
- Acronym / sponsor ID
- PREHAB-HF / 0407-18-FB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 9 Jul 2018 (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 purpose of this study is to test a home-based exergaming intervention designed to decrease frailty and fatigue and improve affective well-being, functional capacity, and immune function in individuals with advanced heart failure (HF) and multiple chronic conditions (MCC) prior to receiving either a left ventricular assist device (LVAD) or orthotopic heart transplantation (OHT). Prior to surgery, individuals with advanced HF/MCC experience a high symptom burden that often precludes them from participating in meaningful physical activity. Pre-surgical fitness programs have been used in other critically ill populations to improve function prior to surgery. Interactive gaming systems have been successfully used to engage other seriously ill adults in low-intensity physical activity. However, exergaming interventions have not yet been applied in individuals with advanced HF/MCC as prehabilitation prior to LVAD implantation or OHT. The investigators propose that a prehabilitation exergaming intervention will not only enhance pre-surgical outcomes but will also augment postoperative outcomes. This study is designed in two-phases. Phase 1 examines intervention feasibility and phase 2 is a pilot study with a two-group design. In phase 2, participants will be randomized to a usual care group or the exergaming intervention group. The exergaming group will participate in a low-intensity exergaming intervention and additional investigator-developed educational modules that will be delivered via the Nintendo Wii U exergaming system. The investigators will evaluate pre- and post-surgical frailty, fatigue, affective well-being, and immune function as primary outcomes. The investigators expect that participation in low intensity exergaming will improve these primary outcomes pre- and post-surgically, and decrease post-surgical complications and health care utilization. Investigator-developed modules will promote self-efficacy, self-regulation, and activation. This is the first study to apply low-intensity exergaming to a pre-operative advanced HF/MCC population. The successful application of this intervention has significant implications to the pre-operative conditioning of individuals with advanced HF/MCC prior to LVAD implantation or OHT.
Detailed description
Specific Aims. The objectives of this study are two-fold: (1) To test the feasibility of a low intensity, home-based exergaming intervention in individuals with advanced HF/MCC prior to left ventricular assist device (LVAD) implantation or orthotopic heart transplantation (OHT), and (2) To examine the effectiveness of delivering a low intensity, home-based exergaming intervention to decrease frailty and fatigue and improve affective well-being, functional capacity, and immune function in individuals with advanced HF/MCC prior to receiving an LVAD or OHT.
Other surgical populations who were deconditioned, fatigued, and frail before surgery have benefited from the use of pre-surgical fitness interventions (prehabilitation).3-5 Innovative interventions strategies, like the Nintendo Wii Fit exergaming system, have been successful at engaging seriously ill adults in low-intensity physical activity6,7. However, exergaming interventions have not yet been applied in individuals with advanced HF as prehabilitation prior to LVAD implantation or OHT. The investigators propose that a home-based, prehabilitation exergaming intervention will not only enhance pre-surgical outcomes but will also augment postoperative outcomes.
The investigators will conduct this study in two phases. Phase 1 is designed as a feasibility study in a smaller sample (5 participants and 5 informal caregivers) to allow initial evaluation of the intervention including troubleshooting the technological components and evaluating study recruitment, retention, and intervention safety prior to initiating the larger, two-group randomized study. Phase 2 will enroll a convenience sample of 40 participants with advanced HF/MCC who are being evaluated for LVAD implantation or OHT at Nebraska Medicine and their 40 informal caregivers for a total sample of 80 enrollees (n=40 exergaming, n=40 usual care).
In both phases, the exergaming group will participate in a low-intensity exergaming intervention and additional investigator-developed educational modules (e.g. symptoms while exercising, exercising with heart failure) that will be delivered via the Nintendo Wii U exergaming system. Investigator-developed modules are designed to promote self-efficacy, self-regulation, and activation. Individuals with advanced HF/MCC will be expected to participate in the exergaming intervention and the investigator-developed modules. Caregivers will be asked to be present for all training sessions and participate in the investigator-developed modules. The investigators will evaluate pre- and post-surgical frailty, fatigue, affective well-being, and immune function as primary outcomes in the individuals with advanced HF/MCC. The investigators expect that participation in low intensity exergaming will improve these primary outcomes pre- and post-surgically, and decrease post-surgical complications and health care utilization. Relationships will be examined among self-efficacy, self-regulation, and activation scores over time, and adherence to the intervention to test whether self-management mechanisms were effective in promoting adherence. Additionally, post-intervention qualitative interviews will be conducted to assess participant and caregiver experiences with the intervention.
Specific aims of this study are the following:
Aim 1 (Phase 1): Evaluate the feasibility of the home-based, low intensity exergaming intervention in individuals with advanced HF/MCC prior to LVAD implantation or OHT and their informal caregivers by assessing recruitment, enrollment, acceptability, adherence, subjects perception of barriers and facilitators, and implementation (delivery, fidelity, and procedures for data collection).
Aim 2 (Phase 2): Evaluate the impact of home-based, low intensity exergaming on pre- and post-surgical outcomes: frailty, fatigue, affective well-being, immune function, and biomarkers of co-morbid conditions at baseline, 4 weeks, and 1 and 3 months post-surgery compared to usual care (All subjects with advanced HF/MCC).
H1. Subjects in the exergaming group will have decreased frailty and fatigue and improved affective well-being and immune function compared to usual care.
Aim 3 (Phase 2): Evaluate the impact of home-based, low intensity exergaming on post-surgical complications (death, infection, bleeding, and rejection) and health care utilization (emergency department visits, unplanned hospital admissions) compared to usual care (both groups of subjects).
H2.a. Subjects in the exergaming group will have fewer post-surgical complications compared to usual care.
H2.b. Subjects in the exergaming group will have fewer emergency department visits and hospital admissions compared to usual care.
Aim 4 (Phase 2): Explore relationships among self-efficacy, self-regulation, and activation scores over time, intervention adherence, and pre- and post-surgical outcomes (Exergaming group participants and caregivers only).
There is a critical need to address deconditioning, fatigue, and frailty in individuals with advanced HF/MCC prior to LVAD implantation or OHT. This innovative exergaming intervention incorporates the use of an interactive, home-based technology to improve pre-and post-surgical outcomes
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergaming | Experimental | Behavioral: PREHABSubjects in the exergaming group will participate in three exergaming training sessions with the Wii Fit U exergaming system. The Wii Fit U will then be left in the subjects' homes for a minimum of four weeks prior to left ventricular assist device implantation or heart transplant. |
| Usual Care | No intervention | –Subjects in the usual care group will be encouraged to partake in physical activity as recommended in the 2017 AHA/ACC/HFSA guidelines for heart failure. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age >19 years
- diagnosis of advanced HF and a minimum of one additional co-occurring chronic condition
- undergoing evaluation for left ventricular assist device implantation or heart transplant
- medical clearance from a heart failure cardiologist in the Nebraska Medicine Advanced HF Clinic.
- the ability to speak and understand English
Key exclusion criteria (6 listed)
- cognitive impairment (Montreal Objective Cognitive Assessment39 [MoCA] < 26), -neuromuscular or orthopedic impairment that would preclude low-intensity physical activity
- unwillingness to complete two supervised sessions in the clinical setting, and one in the home setting
- ongoing inotrope therapy. (Exercise is discouraged during inotrope therapy.)
- inability to pass a Wii Fit Balance Board safety screen (prior to randomization in Phase 2)
- Unwillingness to participate in the supervised exergaming training sessions
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 |
|---|---|---|
| PREHABAfter three supervised training sessions, subjects will be asked to participate in a daily exergaming activity tailored to their physical activity capabilities and needs. Subjects will be taught to rate their perceived exertion and monitor their target heart rate using a Fit Bit Charge HR. Daily exercise diaries will be used to monitor subject-perceived progress throughout the intervention period. | Behavioural | Exergaming |
Primary outcome
Change in Functional Capacity from Baseline
Time frame: Baseline, 1 month post-intervention, 1 & 3 months post-surgery
Functional capacity will be assessed with a six-minute walk test. Subjects will be asked to walk for 6 min to determine what distance they can accomplish in that time period at a normal walking pace.
Change in Physical Frailty from Baseline
Time frame: Baseline, 1 month post-intervention, 1 & 3 months post-surgery
Physical frailty will be assessed using the Fried criteria which include: Unintentional weight loss (10 lbs in past year), exhaustion, weakness (grip strength), slow walking speed, and low physical activity (0 criteria-not frail; 1-2 criteria-pre-frail; ≥3-frail)
Change in Fatigue from Baseline
Time frame: Baseline, 1 month post-intervention, 1 & 3 months post-surgery
Fatigue will be assessed with the NINR Fatigue Common Data Element which is a 6-item self-report 5-item Likert scale. Higher scores indicate greater feelings of fatigue. Max score is 30.
1 secondary outcome
Change in Immune Function from Baseline
Time frame: Baseline, 1 month post-intervention, 1 & 3 months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- 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.
Windy W Alonso, PhD, RN principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREHAB in people with Heart-Assist Devices and Heart Failure NYHA Class IV, run by University of Nebraska at 1 site in United States.
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 7 inclusion and 6 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 29 Sep 2023. 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 United States. 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?
Change in Functional Capacity from Baseline (time frame: Baseline, 1 month post-intervention, 1 & 3 months post-surgery). The study lists 3 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 29 Sep 2023.