StrokeNCT03706105
Integrating Stroke Survivors Into Cardiac Rehabilitation
A study testing Cardiac Rehabilitation in people with Stroke, run by University of South Carolina at 1 site in United States.
Trial summary
The intervention trial will examine the effectiveness and feasibility of integrating stroke survivors into an existing hospital-based cardiac rehabilitation program at Novant Health in Charlotte, NC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Cardiac Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 30 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of stroke
- Completion of physical and occupational therapy (if applicable)
- Clearance by treating medical provider
- Ability to walk at least 40 meters independently (with or without assistive device)
- Ability to transfer sit to stand without assistance
- Ability to follow instructions and provide information on exertion, pain and distress
Who cannot join
- Acute medical problem rendering exercise unsafe
- Significant pain that prevents standing or interferes with movement
- History of additional, non-stroke, neurological condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, 28204
About this study
The intervention trial will examine the effectiveness and feasibility of integrating stroke survivors into an existing hospital-based cardiac rehabilitation program at Novant Health in Charlotte, NC. Stroke survivors will be recruited through hospital system providers and physical therapists (PTs) for entry into a multidisciplinary, three-month cardiac rehabilitation program. This program consists of three sessions per week of supervised cardiovascular endurance and strength training, stretching, relaxation and education. Participants will be stroke survivors, have completed formal physical and occupational rehabilitation (if applicable), and have treating provider approval.
- Conditions
- Stroke
- Being tested
- Cardiac Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac RehabilitationBehavioural
3 x week ~1 hour of exercise + education
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Cardiac Rehabilitation | Experimental | Not described Receives: Behavioral: Cardiac Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk Test
Aerobic and Walking Capacity Measure
Measured: Change in 6-minute walk test at 3 months
Secondary outcomes (8)
Walking Speed
Self-Selected walking speed for 10 meters
Measured: Change in Walking Speed at 3 months
Timed Up and Go
Mobility Measure: timed movement from seated in a chair, walk 10 feet and return to sitting in a chair.
Measured: Change in timed up and go at 3 months
Stroke Impact Scale
Quality of Life Questionnaire evaluating difficulty after stroke in 8 domains: strength, hand function, activities of daily living, mobility, communication, emotion, memory/thinking, participation/role function. Score is 0-100 in each domain and is transformed using the equation Domain score = (mean item score - 1)/4 * 100. Higher Scores indicate less impact of stroke.
Measured: Change in Stroke Impact Scale at 3 months
Fatigue Severity Scale
A scale measuring the perceived impact of fatigue on life activities. Total score is 9-63 with a higher score indicating more fatigue severity and impact.
Measured: Change in Fatigue Severity Scale at 3 months
Activities Specific Balance Confidence (ABC) Scale
The Activities Specific Balance Confidence scale measures an individual's confidence in performing 16 activities without loss of balance. Possible scores are 0-100 with higher scores indicating higher balance confidence.
Measured: Change in ABC Scale at 3 months
Readiness for Change Questionnaire
The readiness for change questionnaire evaluates self-perception of readiness and confidence in exercise, physical activity and overall wellness behaviors. Readiness score is 3-15 with higher scores indicating higher readiness, and confidence score 3-9 with a higher score indicating more confidence in behavior.
Measured: Change in Readiness/Confidence in Behaviors at 3 months
Patient Health Questionnaire 9 (PHQ9)
The patient health questionnaire is a 9 question self report measure of depression and depression severity. The score is 0-27 with a higher score indicating more severe depression.
Measured: Change in PHQ9 at 3 months
Ferrans and Powers Quality of Life Questionnaire
Ferrans and Powers Quality of Life questionnaire is a measure of satisfaction and importance of 7 domains (health, healthcare, self-care, energy, family/friends support, engagement in life activities, happiness). Raw scores are converted to overall scores by weighting satisfaction by importance and adjusting for unanswered questions. Total scores are 0-30 with higher scores indicating a higher quality of life.
Measured: Change in Ferrans and Powers Quality of Life Questionnaire at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start1 Jul 2018
- Primary completion30 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Novant Health Heart and Vascular Institute, American Physical Therapy Association
- Responsible party
- Principal investigator, Elizabeth Regan, University of South Carolina
- Investigators
- Stacy L Fritz, PT, PhD, Study director, University of South CarolinaElizabeth Regan, DPT, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706105
- Sponsor's protocol ID
- 18-1001
- Status last verified
- Nov 2020
- First submitted
- 25 Apr 2018
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Regan EW, Handlery R, Stewart JC, Pearson JL, Wilcox S, Fritz S. Integrating Survivors of Stroke Into Exercise-Based Cardiac Rehabilitation Improves Endurance and Functional Strength. J Am Heart Assoc. 2021 Feb 2;10(3):e017907. doi: 10.1161/JAHA.120.017907. Epub 2021 Jan 27.
PubMed 33499647
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Stroke Survivors Into Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT03706105
- Acronym / sponsor ID
- 18-1001
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Novant Health Heart and Vascular Institute, American Physical Therapy Association
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 15 Oct 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 intervention trial will examine the effectiveness and feasibility of integrating stroke survivors into an existing hospital-based cardiac rehabilitation program at Novant Health in Charlotte, NC. Stroke survivors will be recruited through hospital system providers and physical therapists (PTs) for entry into a multidisciplinary, three-month cardiac rehabilitation program. This program consists of three sessions per week of supervised cardiovascular endurance and strength training, stretching, relaxation and education. Participants will be stroke survivors, have completed formal physical and occupational rehabilitation (if applicable), and have treating provider approval.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention - Cardiac Rehabilitation | Experimental | Behavioral: Cardiac Rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of stroke
- Completion of physical and occupational therapy (if applicable)
- Clearance by treating medical provider
- Ability to walk at least 40 meters independently (with or without assistive device)
- Ability to transfer sit to stand without assistance
Key exclusion criteria (3 listed)
- Acute medical problem rendering exercise unsafe
- Significant pain that prevents standing or interferes with movement
- History of additional, non-stroke, neurological condition
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 |
|---|---|---|
| Cardiac Rehabilitation3 x week ~1 hour of exercise + education | Behavioural | Intervention - Cardiac Rehabilitation |
Primary outcome
6-minute walk Test
Time frame: Change in 6-minute walk test at 3 months
Aerobic and Walking Capacity Measure
8 secondary outcomes
Walking Speed
Time frame: Change in Walking Speed at 3 months
Timed Up and Go
Time frame: Change in timed up and go at 3 months
Stroke Impact Scale
Time frame: Change in Stroke Impact Scale at 3 months
Fatigue Severity Scale
Time frame: Change in Fatigue Severity Scale at 3 months
Activities Specific Balance Confidence (ABC) Scale
Time frame: Change in ABC Scale at 3 months
Readiness for Change Questionnaire
Time frame: Change in Readiness/Confidence in Behaviors at 3 months
Patient Health Questionnaire 9 (PHQ9)
Time frame: Change in PHQ9 at 3 months
Ferrans and Powers Quality of Life Questionnaire
Time frame: Change in Ferrans and Powers Quality of Life Questionnaire at 3 months
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 3 Nov 2020.
- Derived from this study: PubMed 33499647Regan EW, Handlery R, Stewart JC, Pearson JL, Wilcox S, Fritz S. Integrating Survivors of Stroke Into Exercise-Based Cardiac Rehabilitation Improves Endurance and Functional Strength. J Am Heart Assoc. 2021 Feb 2;10(3):e017907. doi: 10.1161/JAHA.120.017907. Epub 2021 Jan 27.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Stacy L Fritz, PT, PhD study director
University of South Carolina
Elizabeth Regan, DPT principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Rehabilitation in people with Stroke, run by University of South Carolina 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 6 inclusion and 3 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 3 Nov 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 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?
6-minute walk Test (time frame: Change in 6-minute walk test at 3 months). 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 NCT03706105, 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 3 Nov 2020.