NCT02425007

Brief Summary

The purpose of this study is to evaluate the efficiency of incentive spirometry in elderly. Outcomes are lung function and chest expansion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable healthy

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, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 26, 2015

Status Verified

November 1, 2015

Enrollment Period

2 months

First QC Date

April 7, 2015

Last Update Submit

November 25, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • lung function will be measured by spirometry

    1 month

Secondary Outcomes (1)

  • Chest expansion will be measured by a tape measure

    One month

Study Arms (2)

Spiro

EXPERIMENTAL

Incentive spirometry

Device: Incentive spirometry

Control

NO INTERVENTION

Control group

Interventions

Incentive spirometryDEVICE
Also known as: Coach
Spiro

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy

You may not qualify if:

  • Pulmonary disease
  • Cognitive disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Brussels, Belgium

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 23, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 26, 2015

Record last verified: 2015-11

Locations

BE(1)