Condition category
Injury, Occupational Diseases, Poisoning
Date applied
04/03/2006
Date assigned
20/04/2006
Last edited
25/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Narcis Gusi

ORCID ID

Contact details

Faculty of Sports Sciences
Caceres
10071
Spain
+34 (0)92 725 74 60
ngusi@unex.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2PR02B017

Study information

Scientific title

Acronym

Study hypothesis

A walk-based exercise programme is cost-effective in a primary care setting

Ethics approval

Approved by the Bioethical Committee of the University of Extremadura on 07/05/2002, reference number: 12/02

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Overweight or moderately depressed older women

Intervention

Three sessions per week of a walk-based exercise programme and recruitment from medical advise in primary care setting. The control group continued to receive usual care (including simple medical exercise advice equal to that of the intervention).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Health related quality of life (costs and utilities)
2. Fitness
3. Anxiety or depression

Secondary outcome measures

1. Medication
2. Lifestyle

Overall trial start date

01/10/2003

Overall trial end date

01/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Women older than 60 years old who are overweight or moderately depressed

Participant type

Patient

Age group

Senior

Gender

Female

Target number of participants

112

Participant exclusion criteria

1. Contraindications to walk-based exercise
2. Cognitive disease
3. Morbid obesity

Recruitment start date

01/10/2003

Recruitment end date

01/10/2004

Locations

Countries of recruitment

Spain

Trial participating centre

Faculty of Sports Sciences
Caceres
10071
Spain

Sponsor information

Organisation

University of Extremadura (Spain)

Sponsor details

Vicerrectorate of Investigation
Avda Elvas s/n
Badajoz
06071
Spain
+34 (0)92 428 93 05
vicein@unex.es

Sponsor type

University/education

Website

http://www.unex.es

Funders

Funder type

Government

Funder name

Research Plan of the Government of Extremadura (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18611277

Publication citations

  1. Results

    Gusi N, Reyes MC, Gonzalez-Guerrero JL, Herrera E, Garcia JM, Cost-utility of a walking programme for moderately depressed, obese, or overweight elderly women in primary care: a randomised controlled trial., BMC Public Health, 2008, 8, 231, doi: 10.1186/1471-2458-8-231.

Additional files

Editorial Notes