NCT02713724

Brief Summary

This study investigates whether an individualized exercise program, including a personal trainer, can improve cardiovascular status quantified with ultrasound to assess coronary flow reserve and other non-invasive techniques. The subjects in the study will be divided into two groups; one group will have a personalized exercise- and nutrition program and the other group will have acess to a gym membership, but no personal trainer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

December 17, 2015

Last Update Submit

September 12, 2016

Conditions

Coronary Artery DiseaseHeart Infarction

Outcome Measures

Primary Outcomes (1)

  • Coronary flow reserve (CFR)

    Ultrasound-assessed coronary flow reserve. Data will be presented as a ratio (no unit) between maximal mean hyperemia flow velocity and baseline velocity

    3-6 months

Secondary Outcomes (5)

  • endothelial function

    3-6 months

  • cIMT (carotid artery intima-media thickness)

    3-6 months

  • metabolic biomarkers

    3-6 months

  • cardiovascular biomarkers

    3-6 months

  • QoL (quality of life)

    3-6 months

Study Arms (2)

DAPS-group

ACTIVE COMPARATOR

Physical exercise

Behavioral: physical exercise

Standard-group

ACTIVE COMPARATOR

Limited physical exercise

Behavioral: limited physical exercise

Interventions

physical exerciseBEHAVIORAL

DAPS-group will follow a personal adjusted training program including instructions from a personal trainer Standard-group will receive a membership at a gym but limited instructions

Also known as: DAPS
DAPS-group
limited physical exerciseBEHAVIORAL

The standard group will receive a membership at a gym but limited instructions and no access to a personal trainer

Also known as: Standard
Standard-group

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • non-smokers
  • no current medication,
  • no known diseases that require regular medication
  • no known risk factor for cardiovascular disease (hypertension, hyperlipidemia, diabetes, heredity, obesity, peripheral vascular disease)
  • no physically fit athletes.

You may not qualify if:

  • ongoing treatment with medicine containing dipyridamole (asasantin, persantin)
  • known hypersensitivity to adenosine
  • chronic obstructive pulmonary disease
  • atrial fibrillation or other obvious arrythmias
  • AV-block grade 2 or higher
  • other serious illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, VG-region, 413 45, Sweden

Location

Related Publications (1)

  • Westergren HU, Gan LM, Mansson M, Svedlund S. Randomized clinical trial studying effects of a personalized supervised lifestyle intervention program on cardiovascular status in physically inactive healthy volunteers. Oncotarget. 2018 Jan 3;9(10):9498-9511. doi: 10.18632/oncotarget.23958. eCollection 2018 Feb 6.

    PMID: 29507706DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Infarction

Interventions

Exercisealpha,beta-diacryloxypropionic acid

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sara Svedlund, MD PhD

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

December 17, 2015

First Posted

March 21, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 13, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)