NCT00737698

Brief Summary

Background Chronic Obstructive Pulmonary Disease (COPD) patients develop leg weakness and a reduced walking capacity, due to reduced leg muscle oxygen-utilising capacity (OUC). Animal experiments indicate that low muscle levels of Peroxisome Proliferator-Activated Receptors (PPAR) cause the reduced muscle OUC. Aims In COPD patients, investigate whether:

  1. 1.reduced muscle PPAR levels cause reduced leg muscle OUC, by investigating a correlation between these in muscle samples (Study 1).
  2. 2.training increases muscle PPAR levels in proportion to increases in OUC, as should occur if PPARs control OUC (Study 2).
  3. 3.muscle PPAR levels and walking capacity correlate (Study 1 and 2).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable chronic-obstructive-pulmonary-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

Study Start

First participant enrolled

January 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
9 years until next milestone

Results Posted

Study results publicly available

September 16, 2019

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1.8 years

First QC Date

August 18, 2008

Results QC Date

April 15, 2019

Last Update Submit

September 27, 2023

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDexerciserepetitive magnetic stimulationquadriceps strength

Outcome Measures

Primary Outcomes (1)

  • Quadriceps Fibre Size of Type IIa Fibres

    Quadriceps fibre cross-sectional area type II a fibres in quadriceps fibre.

    8 weeks

Study Arms (3)

Exercise

EXPERIMENTAL

Exercise

Other: Exercise

Repetitive magnetic stimulation

EXPERIMENTAL

Repetitive magnetic stimulation of femoral nerve

Other: Repetitive magnetic stimulation

Control

NO INTERVENTION

No active treatment

Interventions

ExerciseOTHER

Physiotherapist-supervised exercise course (endurance and resistance exercises) for 2 hours twice a week for 8 weeks

Exercise
Repetitive magnetic stimulationOTHER

Repetitive magnetic stimulation of the intramuscular branches of the femoral nerve for 3 hours twice a week for 8 weeks

Repetitive magnetic stimulation

Eligibility Criteria

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

You may qualify if:

  • Chronic Obstructive Pulmonary Disease

You may not qualify if:

  • Cardiac failure
  • Renal failure
  • Liver failure
  • Diabetes mellitus
  • Systemic inflammatory diseases eg Rheumatoid arthritis, SLE
  • Warfarin, coagulation problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiratory Muscle Lab, Royal Brompton Hospital, Fulham Road

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Interventions

ExerciseTranscranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMagnetic Field TherapyTherapeutics

Results Point of Contact

Title
Dr Samantha Amanda Sathyapala
Organization
Imperial College London
s.sathyapala@imperial.ac.uk
+442073518029

Study Officials

  • Michael I Polkey, MBBSFRCPPhD

    Royal Brompton Hospital/Imperial College

    STUDY DIRECTOR

  • Samantha A Sathyapala, MABMBChPhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wellcome Trust Clinical Research Fellow

Study Record Dates

First Submitted

August 18, 2008

First Posted

August 19, 2008

Study Start

January 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2010

Last Updated

September 28, 2023

Results First Posted

September 16, 2019

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)