NCT01097473

Brief Summary

This controlled study is undertaken to investigate the effects of a long term outpatient training program on physical fitness and quality of life in elderly asthmatics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Apr 1996

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

Study Start

First participant enrolled

April 1, 1996

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 1998

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1998

Completed
12.1 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2010

Completed
Last Updated

April 1, 2010

Status Verified

March 1, 2010

Enrollment Period

1.8 years

First QC Date

March 31, 2010

Last Update Submit

March 31, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maximum oxygen uptake

    Maximum oxygen uptake measured during unsteady state cycle ergometer test with work increments of 10 watts each minute until exhaustion.

    One year

Secondary Outcomes (2)

  • General quality of life

    One year

  • Disease-specific quality of life

    One year

Study Arms (2)

Exercise training

ACTIVE COMPARATOR

Subjects participate in a once weekly supervised exercise training group, duration of 60 min.

Procedure: Exercise training

Control

NO INTERVENTION

Control group receives no intervention

Interventions

Exercise training in outpatient sport groups once weekly with a duration of 60 min each

Exercise training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • physician diagnosed asthma
  • non-smoker
  • stable condition
  • informed consent

You may not qualify if:

  • unability to attend training sessions on a regular basis for one year
  • symptomatic coronary heart disease
  • uncontrolled heart failure
  • hemodynamically relevant cardiac rhythm disorders
  • hemodynamically relevant cardiac valvular disorders
  • uncontrolled arterial hypertension
  • hypercapnic respiratory failure
  • severe hypoxemia (i.e. PaO2 \<50 mm Hg resp. SaO2 \<80% at rest)
  • history of decompensated right heart failure
  • pulmonary arterial hypertension (PA mean pressure at rest \>20 mm Hg)
  • severe osteoporosis
  • severe airway obstruction (FEV1 \<50% predicted, FEV1 \<60% predicted following bronchodilatation)
  • maximum work rate of less than 50 watt during ergometer testing
  • uncontrolled asthma
  • COPD exacerbation
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Location

Related Publications (1)

  • Meyer A, Gunther S, Volmer T, Taube K, Baumann HJ. A 12-month, moderate-intensity exercise training program improves fitness and quality of life in adults with asthma: a controlled trial. BMC Pulm Med. 2015 May 7;15:56. doi: 10.1186/s12890-015-0053-8.

MeSH Terms

Conditions

Asthma

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Andreas Meyer, M.D.

    Kliniken Mariahilf GmbH, Mönchengladbach, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 31, 2010

First Posted

April 1, 2010

Study Start

April 1, 1996

Primary Completion

January 1, 1998

Study Completion

March 1, 1998

Last Updated

April 1, 2010

Record last verified: 2010-03

Locations