NCT00657293

Brief Summary

Patients with chronic lung disease often report shortness of breath when they use their arms for simple activities of daily living such as dressing, lifting, shaving, bathing and brushing their hair and teeth. The best type of arm training for these patients is still unknown. The objectives of this study are to:

  • develop a feasible and safe arm training program (ATP) for these patients;
  • examine the effects of this ATP on quality of life, arm function, arm exercise capacity and symptoms during activities of daily living;
  • examine the effects of ATP on breathing responses during arm exercises.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jul 2008

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 22, 2010

Status Verified

February 1, 2010

Enrollment Period

1.5 years

First QC Date

April 8, 2008

Last Update Submit

February 19, 2010

Conditions

Keywords

COPDarm trainingdyspnoeaquality of life

Outcome Measures

Primary Outcomes (1)

  • Feasibility measures, dyspnoea during activities of daily living, fatigue, health-related quality of life, unsupported arm exercise capacity, arm function and peripheral muscle force

    Primary outcome measures will be collected before PR program, on completion of the PR program (at 6 weeks) and at three months following completion of the PR program.

Secondary Outcomes (1)

  • Peak cardiorespiratory responses during incremental unsupported upper limb exercise test

    Secondary outcome measures will be collected before PR program, on completion of the PR program (at 6 weeks) and at three months following completion of the PR program.

Study Arms (2)

C

SHAM COMPARATOR

In an attempt to make the groups comparable in terms of attention, the control group will receive a sham.

Behavioral: Purdue pegboard test (sham)

ATP

ACTIVE COMPARATOR

Patients will undergo a specific arm training program (ATP).

Behavioral: Arm training program

Interventions

Patients will undergo a specific arm training program (ATP) three times a week for the duration of the 6 week program. The ATP will consist predominantly of resistance exercises. Muscle groups targeted during the ATP will include deltoid, biceps and triceps, pectoralis and latissimus. Subjects will train using multi station gym equipment and free weights.

ATP

In an attempt to make the groups comparable in terms of attention, the control group will perform the purdue pegboard test of finger dexterity. The tasks will be performed in a sitting position with the arms supported on a table. This test will consist of 4 timed tasks where as many pins as possible will be placed on a pegboard in a given time. Performance of the pegboard test is likely to improve with practice which may serve to motivate the patients to continue practicing over the 6-week period. Subjects will perform this activity 3 times per week with supervision provided by a physiotherapist.

C

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • a diagnosis of COPD
  • a forced expiratory volume in one second (FEV1) of less than 80% the predicted normal value
  • must report dyspnoea during at least one activity of daily living that requires arm activity
  • must have a smoking history greater than 10 pack years and
  • must be able to provide written informed consent

You may not qualify if:

  • acute exacerbation of COPD that required a change in pharmacological management within the preceding two months
  • an inability to understand English
  • cognitive impairment
  • requirement for mechanical ventilation for all or part of the day
  • tapering doses of oral corticosteroids or xanthines
  • evidence of a musculoskeletal or neurological condition which could adversely affect arm exercise performance
  • symptomatic ischemic cardiac disease
  • a history of previous lung surgery and alpha1 antitrypsin deficient emphysema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Roger Goldstein, M.D.

    West Park Healthcare Centre

    PRINCIPAL INVESTIGATOR
  • Dina Brooks, Ph.D.

    West Park Healthcare Centre

    PRINCIPAL INVESTIGATOR
  • Tania Janaudis-Ferreira, Msc

    West Park Healthcare Centre

    STUDY CHAIR
  • Kylie Hill, Ph.D.

    West Park Healthcare Centre

    STUDY CHAIR
  • Tom Dolmage, Msc

    West Park Healthcare Centre

    STUDY CHAIR
  • Marla Beauchamp, Msc

    West Park Healthcare Centre

    STUDY CHAIR
  • Karin Wadell, Ph.D.

    Umea University

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

April 8, 2008

First Posted

April 14, 2008

Study Start

July 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

February 22, 2010

Record last verified: 2010-02

Locations