NCT01850173

Brief Summary

The investigators designed the current study with the main objective of determining whether Whole Body Vibration Training (WBVT) alone improves muscular force and/or modifies the functional capacity parameters in severe Chronic Obstructive Pulmonary Disease (COPD) patients referred to a rehabilitation programme.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration 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

February 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 9, 2013

Completed
Last Updated

May 9, 2013

Status Verified

May 1, 2013

Enrollment Period

1.8 years

First QC Date

May 2, 2013

Last Update Submit

May 6, 2013

Conditions

Outcome Measures

Primary Outcomes (2)

  • isokinetic knee flexor and extensor testing muscular force

    the change between basal - and 3 months follow up.

    basal, 3 months follow up

  • distance performed in the six minutes walking test (6MWT)

    the change between basal - and 3 months follow up.

    Basal, 3 months follow up

Secondary Outcomes (1)

  • respiratory muscular strength was assessed with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)

    Basal, 3 month follow up

Other Outcomes (1)

  • Complications

    3 months follow up

Study Arms (2)

static work with a vertical vibration platform

EXPERIMENTAL

The training was designed to perform static work of the lower limbs. Patients worked in a squatting position, with 30º of hip flexion and 55º of knee flexion, holding onto the bars of the WBV platform.

Device: A vertical vibration platform Fitybe

Control group

NO INTERVENTION

general recommendations about physical activity and lifestyle

Interventions

They performed 6 series, and each series consisted of four 30-second repetitions with a frequency of 35 Hz and 2 millimeters of amplitude, with 60 seconds of rest between each series.

static work with a vertical vibration platform

Eligibility Criteria

Age55 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • severe COPD defined as a post-bronchodilator forced expiratory volume at one second (FEV1)/ forced vital capacity (FVC) \< 0.7 and FEV1 \< 50% predicted,
  • stable disease defined as no exacerbation,
  • hospital admission or change in treatment in the previous 3 months.

You may not qualify if:

  • other significant respiratory disease (bronchiectasis,
  • lung fibrosis, asthma, etc),
  • active smoking,
  • severe cardiovascular,
  • neurological, and/or metabolic pathology that could interfere with the results,
  • total hip, knee or ankle arthroplasty,
  • previous vitreous haemorrhage,
  • severe alcoholism (\> 80 g/day) and
  • severe malnutrition (BMI \< 19 Kg/m2) to reduce the risk of falling and dropouts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eulogio Pleguezuelos

Mataró, Barcelona, 08304, Spain

Location

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Eulogio Pleguezuelos, PhD

    Hospital de Mataró

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 2, 2013

First Posted

May 9, 2013

Study Start

February 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 9, 2013

Record last verified: 2013-05

Locations