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Remote Exercise SWEDEHEART Study

Primary Purpose

Myocardial Infarction

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Exercise-based cardiac rehabilitation
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Exercise-based cardiac rehabilitation, Secondary prevention, EHealth, Telerehabilitation, Physical fitness, Health-related quality of life, cost-effectiveness

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Written informed consent
  • Diagnosis of acute myocardial infarction (AMI)
  • Age 18-79 years at discharge from hospital

Exclusion Criteria:

  • Patients with incomplete coronary revascularization defined as at least one remaining hemodynamically significant stenosis
  • Severe valve or structural heart disease
  • Severe heart failure (NYHA III - IV)
  • Serious arrythmias
  • Inability to understand Swedish
  • No internet access at home (only applicable for intervention group)
  • Any condition that may interfere with the possibility for the patient to comply with the study protocol

Sites / Locations

  • Södra Älvsborg HospitalRecruiting
  • MälarsjukhusetRecruiting
  • Falun hospitalRecruiting
  • Angered HospitalRecruiting
  • Sahlgrenska University Hospital ÖstraRecruiting
  • Sahlgrenska University HospitalRecruiting
  • Gällivare HospitalRecruiting
  • Gävle HospitalRecruiting
  • Hässleholm HospitalRecruiting
  • Jönköping Ryhov hospitalRecruiting
  • Kalix hospitalRecruiting
  • Kalmar HospitalRecruiting
  • Kungälv HospitalRecruiting
  • Lindesberg HospitalRecruiting
  • Linköping University HospitalRecruiting
  • Ljungby HospitalRecruiting
  • Sunderbyn hospitalRecruiting
  • Skåne University hospitalRecruiting
  • Skåne University Hospital MalmöRecruiting
  • Capio St Göran HospitalRecruiting
  • Karolinska University HospitalRecruiting
  • Sundsvall hospitalRecruiting
  • Södertälje HospitalRecruiting
  • Uppsala University HopsitalRecruiting
  • Värnamo hospitalRecruiting
  • Östersund hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention center

Control

Arm Description

Patients at intervention centers will be offered remote video exCR (first-hand option), usual care centre-based exCR or a combination. The exercise program (remote/centre-based) will be standardized and performed for totally 60 minutes, 2 times a week for 3 months. Exercise will be individually prescribed and progressed by physiotherapists in accordance with guidelines. Patients will also be asked to perform one additional session of at least 30 min aerobic exercise per week, at intensity level 13-15 according to Borg RPE-scale.

At control centers, patients will be offered usual care centre-based exCR only. Patients will also be asked to perform one additional session of at least 30 min aerobic exercise per week, at intensity level 13-15 according to Borg RPE-scale.

Outcomes

Primary Outcome Measures

Mean number of exCR sessions
The primary outcome is the mean number of EBCR sessions (center based or remote) during 0-4 months (from start of the EBCR program) for patients at a center during each randomization period. Eligible patients that have not started the EBCR program within 6 months of screening will be counted as 0 sessions. Attending ≥75% of the 24 recommended sessions over a 4-month period will be considered as completion, and proportion completers will be presented in a supportive responder analysis.

Secondary Outcome Measures

Submaximal exercise capacity
Bicycle ergometer test according to the WHO-protocol with an increased workload of 25W every 4.5 minutes. The exercise test is discontinued at Borg RPE 17 and/or dyspnea 7 at Borg´s CR-10 scale.
Muscular endurance tests
Unilateral isotonic shoulder flexion (maximum number of repetitions) and a unilateral isotonic heel lift (maximum number of repetitions)
Self-reported physical activity and exercise
Two questions on physical activity and exercise during the latest week according to Haskell´s questionnaire (Min:0, Max:7). Ordinal scale, number of days.
Self-reported physical activity and exercise Haskell
Haskell´s questionnaire (Min:0, Max:7). A high score means higher level of physical activity and exercise.
Self-reported physical capacity
Visual analog scale, (100=best possible physical capacity, 0=worst possible physical capacity), a dichotomous question: Do you experience any limitation in everyday life due to your current physical capacity? (yes vs no). If yes: multiple choice on reasons
Health-related quality of life EQ5D
Euro Quality of Life (EQ-5D 3L). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. A high score indicates better Health.
Health-related quality of life VAS
Euro Quality of Life VAS. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state'(100) and 'Worst imaginable health state' (0)
Kinesiophobia (fear of movement)
Tampa Scale for Kinesiophobia Heart (17 items, ordinal scale 1-4) 1, strongly disagree, 4, strongly agree. A higher score is means higher values of kinesiophobia (worse).
Self-efficacy for Exercise Scale
Self-efficacy for Exercise Scale. 9 items, ordinal scale. 0=not Confident, 10=very Confident. Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise
Self-reported perceptions on exercise
Patient´s perceptions of remote exCR or centre-based exCR. 1, strongly disagree, 4, strongly agree. This questionnarie is designed by the authors. High score, better outcome.
Cost-effectiveness
A cost-effectiveness analysis will be performed in order to estimate the cost per quality-adjusted life-year (QALY) associated with the intervention compared with control. Healthcare costs associated with investigated treatments will be assessed by extracting resource use from the relevant registries, and QALYs will be determined by combining survival status and the quality-of-life measurements provided by the EQ-5D-3L instrument.
Socio-economic evaluation
Data from Statistics Sweden will be used to evaluate study results in relation to socio-economic data
Number of Cardiovascular events
All-cause mortality, cardiovascular mortality, recurrent hospitalization for ACS, heart failure hospitalization, stroke and repeat coronary revascularization, reported in SWEDEHEART, the National Patient Registry and the Cause of Death Register will be performed.

Full Information

First Posted
February 4, 2020
Last Updated
July 4, 2023
Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Göteborg University, Linkoeping University, Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT04260958
Brief Title
Remote Exercise SWEDEHEART Study
Official Title
Remote Exercise SWEDEHEART Study - a Multicentre Registry-based Cluster Randomized Crossover Clinical Trial (RRCT)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Göteborg University, Linkoeping University, Uppsala University

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 overall aim of the study is to evaluate if remote video exercise-based cardiac rehabilitation (exCR), offered as an alternative to centre-based exCR, can increase participation in exCR sessions post myocardial infarction (MI).
Detailed Description
Due to the covid-19 pandemic, this study will be performed in two steps: 1). National feasibility and safety study. 2). National multicenter registry-based cluster randomized crossover clinical trial (RRCT). In the feasibility study, patients will be offered remote exCR at all participating sites until the peak of the pandemic has been achieved and care goes back to normal. The feasibility study will include patients until Aug 2022. CR centers (not patients) will be cluster randomized to either the intervention or control. Patients at intervention centers will be offered remote exCR, usual care centre-based exCR, or a combination of both modes, as self-preferred choice. At control centers, patients will be offered usual care centre-based exCR only. The duration of each time period for each center will be 15 months. Long-term follow-up will be performed 1 year and 3 years after the index cardiac event.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Exercise-based cardiac rehabilitation, Secondary prevention, EHealth, Telerehabilitation, Physical fitness, Health-related quality of life, cost-effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
CR centers will be cluster randomized and start as either the intervention or control center. Patients at intervention centers will be offered remote video exCR (first-hand option), usual care centre-based exCR or a combination of these two exercise modes. At control centers, patients will be offered usual care centre-based exCR only. The duration of each time period for each center will be 15 months and then cross-over will occur, so that intervention centers become control centers and the other way around. At intervention centers, patients participating in remote exCR will finish their 3-month exercise period, but no new patients will be offered remote exCR after the cross-over has occurred.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention center
Arm Type
Experimental
Arm Description
Patients at intervention centers will be offered remote video exCR (first-hand option), usual care centre-based exCR or a combination. The exercise program (remote/centre-based) will be standardized and performed for totally 60 minutes, 2 times a week for 3 months. Exercise will be individually prescribed and progressed by physiotherapists in accordance with guidelines. Patients will also be asked to perform one additional session of at least 30 min aerobic exercise per week, at intensity level 13-15 according to Borg RPE-scale.
Arm Title
Control
Arm Type
No Intervention
Arm Description
At control centers, patients will be offered usual care centre-based exCR only. Patients will also be asked to perform one additional session of at least 30 min aerobic exercise per week, at intensity level 13-15 according to Borg RPE-scale.
Intervention Type
Other
Intervention Name(s)
Exercise-based cardiac rehabilitation
Intervention Description
The exercise program (remote/centre-based) will be standardized. An exCR-program is defined as at least 24 supervised sessions, with a total session length of 60 minutes, for at least 3 months, with possibility to complete missed sessions the 4th month. Each exercise session includes at least 20 min of aerobic exercise, intensity 13-17 on Borg´s rating of perceived exertion (RPE)-scale ≈ 60% - 85% of VO2max or 70 - 95% of maximal heart rate. In addition, each exercise session includes 1-3 sets of 8-10 upper and/or lower limb exercises in 10-15 repetitions, 40-80% of 1 repetition maximum. Attending ≥75% of the 24 sessions over a 4-month period will be considered as successful.
Primary Outcome Measure Information:
Title
Mean number of exCR sessions
Description
The primary outcome is the mean number of EBCR sessions (center based or remote) during 0-4 months (from start of the EBCR program) for patients at a center during each randomization period. Eligible patients that have not started the EBCR program within 6 months of screening will be counted as 0 sessions. Attending ≥75% of the 24 recommended sessions over a 4-month period will be considered as completion, and proportion completers will be presented in a supportive responder analysis.
Time Frame
3-4 months
Secondary Outcome Measure Information:
Title
Submaximal exercise capacity
Description
Bicycle ergometer test according to the WHO-protocol with an increased workload of 25W every 4.5 minutes. The exercise test is discontinued at Borg RPE 17 and/or dyspnea 7 at Borg´s CR-10 scale.
Time Frame
3-4 months
Title
Muscular endurance tests
Description
Unilateral isotonic shoulder flexion (maximum number of repetitions) and a unilateral isotonic heel lift (maximum number of repetitions)
Time Frame
3-4 months
Title
Self-reported physical activity and exercise
Description
Two questions on physical activity and exercise during the latest week according to Haskell´s questionnaire (Min:0, Max:7). Ordinal scale, number of days.
Time Frame
3-4 months
Title
Self-reported physical activity and exercise Haskell
Description
Haskell´s questionnaire (Min:0, Max:7). A high score means higher level of physical activity and exercise.
Time Frame
3-4 months
Title
Self-reported physical capacity
Description
Visual analog scale, (100=best possible physical capacity, 0=worst possible physical capacity), a dichotomous question: Do you experience any limitation in everyday life due to your current physical capacity? (yes vs no). If yes: multiple choice on reasons
Time Frame
3-4 months
Title
Health-related quality of life EQ5D
Description
Euro Quality of Life (EQ-5D 3L). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. A high score indicates better Health.
Time Frame
3-4 months
Title
Health-related quality of life VAS
Description
Euro Quality of Life VAS. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state'(100) and 'Worst imaginable health state' (0)
Time Frame
3-4 months
Title
Kinesiophobia (fear of movement)
Description
Tampa Scale for Kinesiophobia Heart (17 items, ordinal scale 1-4) 1, strongly disagree, 4, strongly agree. A higher score is means higher values of kinesiophobia (worse).
Time Frame
3-4 months
Title
Self-efficacy for Exercise Scale
Description
Self-efficacy for Exercise Scale. 9 items, ordinal scale. 0=not Confident, 10=very Confident. Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise
Time Frame
3-4 months
Title
Self-reported perceptions on exercise
Description
Patient´s perceptions of remote exCR or centre-based exCR. 1, strongly disagree, 4, strongly agree. This questionnarie is designed by the authors. High score, better outcome.
Time Frame
3-4 months
Title
Cost-effectiveness
Description
A cost-effectiveness analysis will be performed in order to estimate the cost per quality-adjusted life-year (QALY) associated with the intervention compared with control. Healthcare costs associated with investigated treatments will be assessed by extracting resource use from the relevant registries, and QALYs will be determined by combining survival status and the quality-of-life measurements provided by the EQ-5D-3L instrument.
Time Frame
End of study
Title
Socio-economic evaluation
Description
Data from Statistics Sweden will be used to evaluate study results in relation to socio-economic data
Time Frame
6 years
Title
Number of Cardiovascular events
Description
All-cause mortality, cardiovascular mortality, recurrent hospitalization for ACS, heart failure hospitalization, stroke and repeat coronary revascularization, reported in SWEDEHEART, the National Patient Registry and the Cause of Death Register will be performed.
Time Frame
1 and 3 years after the last patient visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent Diagnosis of type 1 myocardial infarction (AMI) Age 18-79 years at discharge from hospital Exclusion Criteria: Patients with incomplete coronary revascularization defined as at least one remaining hemodynamically significant stenosis Severe valve or structural heart disease Severe heart failure (NYHA III - IV) Serious arrythmias Inability to understand Swedish No internet access at home (only applicable for patients in the intervention group who wants to perform remote exCR) Pathological exercise test indicating high risk for adverse events during exCR More than 6 months between discharge form hospital and screening Any other condition that may interfere with the possibility for the patient to comply with the study protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Back, Ass Prof
Phone
+46700895612
Email
maria.m.back@vgregion.se
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Palmcrantz Graf
Phone
+46186119542
Email
elisabeth.palmcrantz-graf@ucr.uu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Back, Ass Prof
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefan James, Prof
Organizational Affiliation
Uppsala Clinial Research Center
Official's Role
Study Chair
Facility Information:
Facility Name
Södra Älvsborg Hospital
City
Borås
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellinor Nylund, RPT
Email
ellinor.nylund@vgregion.se
First Name & Middle Initial & Last Name & Degree
Ellinor Nylund, RPT
Facility Name
Mälarsjukhuset
City
Eskilstuna
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annalina Anduri Ohlsson, RPT
Email
Annalina.Anduri.Ohlsson@regionsormland.se;
Facility Name
Falun hospital
City
Falun
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lovisa Wahlen, RPT
Email
lovisa.wahlen@regiondalarna.se
First Name & Middle Initial & Last Name & Degree
Lovisa Wahlen, RPT
Facility Name
Angered Hospital
City
Gothenburg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aziza Ferreira, RPT
Email
aziza.ferreira@vgregion.se
Facility Name
Sahlgrenska University Hospital Östra
City
Gothenburg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klara Emanuelsson Hummel, RPT
Email
klara.emanuelsson@vgregion.se
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Bäck, PhD
Email
maria.m.back@vgregion.se
First Name & Middle Initial & Last Name & Degree
Maria Back, Ass Prof
Facility Name
Gällivare Hospital
City
Gällivare
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Fabricius, RPT
Email
sara.fabricius@norrbotten.se
Facility Name
Gävle Hospital
City
Gävle
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Forsgren, RPT
Email
anna.erin.forsgren@regiongavleborg.se;
Facility Name
Hässleholm Hospital
City
Hässleholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Larsson, RPT
Email
sandra.larsson@skane.se
Facility Name
Jönköping Ryhov hospital
City
Jönköping
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Sahlin, RPT
Email
maria.sahlin@rjl.se
First Name & Middle Initial & Last Name & Degree
Maria Sahlin, RPT
Facility Name
Kalix hospital
City
Kalix
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Öberg, RPT
Email
eva.oberg@norrbotten.se
First Name & Middle Initial & Last Name & Degree
Eva Öberg, RPT
Facility Name
Kalmar Hospital
City
Kalmar
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotta Lans, PhD
Email
charlotta.lans@regionkalmar.se
Facility Name
Kungälv Hospital
City
Kungälv
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Nyth Persson, RPT
Email
tina.nyth.persson@vgregion.se
Facility Name
Lindesberg Hospital
City
Lindesberg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcus Bargholtz, MSc
Email
marcus.bargholtz@regionorebrolan.se
Facility Name
Linköping University Hospital
City
Linköping
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabina Borg, RPT
Email
sabina.borg@liu.se
First Name & Middle Initial & Last Name & Degree
Sabina Borg, RPT
Facility Name
Ljungby Hospital
City
Ljungby
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Olovsson, RPT
Email
Jessica.Olovsson@kronoberg.se;
Facility Name
Sunderbyn hospital
City
Luleå
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena Bergström, RPT
Email
lena.m.bergstrom@norrbotten.se
First Name & Middle Initial & Last Name & Degree
Lena Bergström, RPT
Facility Name
Skåne University hospital
City
Lund
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Holm, RPT
Email
simon.holm@skane.se
First Name & Middle Initial & Last Name & Degree
Simon Holm, RPT
Facility Name
Skåne University Hospital Malmö
City
Malmö
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margret Leosdottir, PhD
Email
margret.leosdottir@skane.se
Facility Name
Capio St Göran Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofia Haghanipour, RPT
Email
sofia.haghanipour@capiostgoran.se
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Lönn, PhD
Email
amanda.lonn@gih.se
Facility Name
Sundsvall hospital
City
Sundsvall
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annika Henriksson
Email
annika.henriksson@rvn.se
First Name & Middle Initial & Last Name & Degree
Kajsa Hedin
Facility Name
Södertälje Hospital
City
Södertälje
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Jäderlund, MSc
Email
maria.jaderlund@sll.se
Facility Name
Uppsala University Hopsital
City
Uppsala
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Urell, PhD
Email
charlotte.urell@neuro.uu.se
Facility Name
Värnamo hospital
City
Värnamo
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monia Lennnartsson, RPT
Email
monia.lennartsson@rjl.se
First Name & Middle Initial & Last Name & Degree
Monia Lennartsson, RPT
Facility Name
Östersund hospital
City
Östersund
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mattias Pettersson, RPT
Email
mattias.pettersson@regionjh.se
First Name & Middle Initial & Last Name & Degree
Mattias Pettersson, RPT

12. IPD Sharing Statement

Plan to Share IPD
No

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Remote Exercise SWEDEHEART Study

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