Condition category
Respiratory
Date applied
23/02/2007
Date assigned
29/03/2007
Last edited
30/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Attila Somfay

ORCID ID

Contact details

Alkotmany u 36
Deszk
6772
Hungary

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Interval training 01

Study information

Scientific title

Acronym

INTCONT

Study hypothesis

To determine differences in responses to supervised high intensity training utilizing either continuous or interval training profiles compared to a self-paced exercise program.

Ethics approval

The Regional Ethical Committee on Biomedical Research Involving Human Subjects at Szeged University, Faculty of Medicine and Pharmaceutics approved the study on 18 December 2006 with a reference number 134/2006.

Study design

Randomized trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Moderate to severe COPD patients

Intervention

Three study groups will be studied:

A. Supervised, high intensity continuous training
B. Supervised, interval training
C. Home-based self paced training program

The assignment of patients to group C will be based on the accessibility of the research center to the patients. We have to use this approach because the travel distance in the area would be unreasonable. The assignment of the subjects to the other two groups (A and B) is randomized.

High intensity constant work rate (CWR) training protocol involved exercising on a cycle ergometer at a work rate equivalent to 80% peak work rate achieved on a pre-training incremental exercise test. The CWR was continued for 45 minutes per session, three sessions per week for 8-week training period.

Interval training: involved a 30 min period of cycling for 2 minutes at 90% peak work rate followed by 1 minute at 50% peak work rate. This 30 min period was preceded and followed by approximately 7.5 minutes of exercise at 50% peak work rate (warm-up and cool-down phase).

Home training involved cycling, stair climbing and walking in their natural environment with the same weekly periodicity and time interval as used in the in-center programs. The home training period also lasted for 8 weeks.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Change in peak oxygen uptake in the incremental test.

Secondary outcome measures

1. After training changes in peak work rate
2. Quality of life
3. Lactate threshold
4. Changes in isotime physiologic variables (minute ventilation, ventilatory equivalents, respiratory rate and heart rate)

Overall trial start date

07/01/2002

Overall trial end date

02/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. COPD patients
2. Forced Expiratory Volume in the first second (FEV1)<80% and FEV1/ Forced Vital Capacity (FVC)<70%

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

Severe cardiovascular, neurological or exercise-limiting muskuloskeletal diseases

Recruitment start date

07/01/2002

Recruitment end date

02/01/2008

Locations

Countries of recruitment

Hungary

Trial participating centre

Alkotmany u 36
Deszk
6772
Hungary

Sponsor information

Organisation

Department of Pulmonology, Szeged University, Faculty of Medicine and Pharmaceutics (Hungary)

Sponsor details

Alkotm√°ny u 36
Deszk
6772
Hungary

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Department of Pulmonology, Szeged University, Faculty of Medicine and Pharmeceutics (Hungary)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes