NCT02025257

Brief Summary

The purpose of this study is to investigate the effects of exercise for patients with coronary artery disease (CAD) aged 80 years and older, with special reference to maximum aerobic capacity, muscle endurance, physical functioning, level of physical activity, health related quality of life, anxiety, depression and endothelial function, compared to a control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 21, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 1, 2014

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

5.4 years

First QC Date

October 21, 2013

Last Update Submit

April 10, 2022

Conditions

Coronary Artery Disease

Keywords

coronary artery diseaseelderlyexerciseexercise-based cardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change in maximum aerobic capacity

    A maximum exercise test on an electronically braked cycle ergometer, with watts as marker of maximum aerobic capacity.

    At baseline and after 4 months

Secondary Outcomes (7)

  • Change in level of physical activity

    At baseline and after 4 months

  • Change in muscular endurance

    At baseline and after 4 months

  • Change in physical functioning

    At baseline and after 4 months

  • Change in health related quality of life

    At baselline and after 4 months

  • Change in anxiety and depression

    At baseline and after 4 months

  • +2 more secondary outcomes

Study Arms (2)

Exercise

EXPERIMENTAL

Individually prescribed hospital based exercise in group two times a week, home-based exercise once a week. The exercise intervention consists of interval based aerobic exercise on a bicycle ergometer 30 minutes with intensity level at 13-17 at Borg scale, resistance exercises and balance exercises

Other: Exercise

Control

NO INTERVENTION

Patients are asked to live as usual.

Interventions

ExerciseOTHER

Individually prescribed hospital based exercise in group two times a week, home-based exercise once a week. The exercise intervention consists of interval based aerobic exercise on a bicycle ergometer 30 minutes with intensity level at 13-17 at Borg scale, resistance exercises and balance exercises

Exercise

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Clinical diagnosis of acute coronary artery disease
  • Aged 80 years or older

You may not qualify if:

  • Inability to understand or speak the Swedish language
  • Serious physical or psychological disease interfering with participation in an exercise intervention
  • Patients are already exercising three times or more/week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of physiotherapy, Sahlgrenska University Hospital

Gothenburg, Select A State…, 41345, Sweden

Location

Related Publications (1)

  • Brosved M, Hirlekar G, Philip Wigh J, Sundberg H, Ziden L, Karlsson T, Albertsson P, Back M. Effects of Cardiac Rehabilitation on Physical Fitness, Physical Function, and Self-reported Outcomes in Patients >/=80 yr: A RANDOMIZED CONTROLLED TRIAL. J Cardiopulm Rehabil Prev. 2022 Sep 1;42(5):331-337. doi: 10.1097/HCR.0000000000000683. Epub 2022 Mar 31.

    PMID: 35362694RESULT

MeSH Terms

Conditions

Coronary Artery DiseaseMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Maria Bäck, PhD

    Department of Physiotherapy, Sahlgrenska University Hospital, Gothenburg, Sweden

    PRINCIPAL INVESTIGATOR

  • Per Albertsson, PhD

    Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd, RPT

Study Record Dates

First Submitted

October 21, 2013

First Posted

January 1, 2014

Study Start

December 1, 2013

Primary Completion

May 1, 2019

Study Completion

April 1, 2022

Last Updated

April 15, 2022

Record last verified: 2022-04

Locations

SE(1)