NCT01981200

Brief Summary

To examine the feasibility of progressive unilateral knee-extension strength training using ankle weight cuffs in patients hospitalized due to acute exacerbation in COPD

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

October 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 11, 2014

Status Verified

February 1, 2014

Enrollment Period

3 months

First QC Date

October 30, 2013

Last Update Submit

February 9, 2014

Conditions

Keywords

COPD acute exacerbationPhysiotherapyResistance trainingMuscle strengthHandheld dynamometer

Outcome Measures

Primary Outcomes (1)

  • Increase of training load during admission

    Change in training loads measured by the number of kilos lifted using ankle weight cuffs in 3 sets of 10 repetition maximum at the first training day to the number of kilos lifted at the last training day

    The patients will be followed for the duration of hospital stay, an expected average of 6 days

Secondary Outcomes (3)

  • Maximal isometric knee extension strength

    The patients will be followed for the duration of hospital stay, an expected average of 6 days

  • Sit-to- stand- test

    The patients will be followed for the duration of hospital stay, an expected average of 6 days

  • Timed Up and Go (TUG)

    The patients will be followed for the duration of hospital stay, an expected average of 6 days

Study Arms (1)

Resistance training in AECOPD

EXPERIMENTAL

The patients conduct daily training during admission with weight cuff 3 set of 10 rep.

Other: Resistance training in AECOPD

Interventions

The patients begin training on day 1 of admittance. The training consists of knee extension performed in the sitting position on the bed with a 90 degrees of flexion of the knees. The weight cuffs are tired to the angles with a weight corresponding to 10 RM (the weight lifted 10 times). The weights and exercises are subjected to supervision on daily basis by the physiotherapist. The weight is increased after every set of training if more than 10 rep. can be performed with a given weight. Limitations to exercise is also recorded along with the degree of dyspnoea as assessed by the Borg CR10, possible oxygen supplementation and saturation is recorded before and following exercise.

Also known as: Weight cuffs, Strength training, hospitalization
Resistance training in AECOPD

Eligibility Criteria

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

You may qualify if:

  • Have a primary diagnosis of COPD
  • Be admitted to the pulmonary ward due to an exacerbation in COPD
  • Provide informed consent to participation in the study
  • Be able to maintain an upright position on a chair
  • Be able to be guided to training and understand instructions for participating

You may not qualify if:

  • Patients suffering from diseases that prevents the use of wrist weights such as
  • Deep venous thrombosis (DVT)
  • Erysipelas
  • Painful edema of the limbs
  • Lack of ability to walk, habitually
  • Predicted hospital stay of less than four days as predicted by a pulmonary physician
  • Patients admitted Friday night or Saturday morning cannot be stared up within 24 hours of admittance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nordsjællands Hospital - Frederikssund

Frederikssund, 3600, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMuscle Weakness

Interventions

Resistance TrainingHospitalization

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Linette M Kofod, PT

    Nordsjællands Hospital - Frederikssund

    PRINCIPAL INVESTIGATOR
  • Morten T Kristensen, PhD

    Copenhagen University Hospital, Hvidovre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 11, 2013

Study Start

October 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

February 11, 2014

Record last verified: 2014-02

Locations