Condition category
Not Applicable
Date applied
24/06/2005
Date assigned
28/07/2005
Last edited
13/08/2012
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 Maureen Simmonds

ORCID ID

Contact details

Professor and Director
School of Physical and Occupational Therapy
McGill University
3654 Promenade Sir-William-Osler
Montreal
Quebec
H3G 1Y5
Canada
+1 514 398 8864
simmondsm@uthscsa.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3134

Study information

Scientific title

Acronym

Study hypothesis

1. Can subjects be effectively recruited?
2. Can both exercise therapies (study and control) be safely employed in an older adult population?
3. Can strategies be developed to ensure acceptable patient compliance?
4. Can appropriate quality assurance initiatives (e.g. patient recruitment, staff training, data collection) be developed to ensure the successful completion of a larger study?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

Healthy older adults

Intervention

An interval-brisk-walking-training program consisting of three sessions per week for 4 weeks. The subjects will participate in a supervised indoor/outdoor training program consisting of repetitions of 30 seconds of brisk walking followed by 3 minutes of recovery walking.

The control group will attend a one-hour training session on the principles of exercise. Participants will be advised to perform moderate endurance exercise at home, such as walking, gardening and swimming three sessions per week for one month.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Six-Minute Walk
2. Fifty-Foot Fast Walk

Secondary outcome measures

1. Stroop Color-Word Test
2. Symbol-Digits Modalities Test
3. Five-Minute Walk
4. Repeated Sit-to-Stand
5. Repeated Trunk Flexion
6. Dynamic Balance
7. Medical Outcomes Study Short-form Health Survey 36-items

Overall trial start date

23/06/2005

Overall trial end date

01/09/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. English literacy
2. Age 65 to 75 years
3. Accessible by telephone
4. Vision and hearing adequate to complete the tasks administered in this study
5. Signed informed consent (not by proxy)
6. Nonsmoker
7. At least 30 minutes of physical activity at least 3 days per week

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

10

Participant exclusion criteria

1. Orthopedic and gait influencing conditions (e.g. severe chronic low back pain)
2. Cognitive deficits (e.g. self-reported diagnosis of Alzheimer’s disease)
3. Medical contraindication to exercise or severe coexisting disease which would interfere with performance
3.1. current cancer
3.2. major surgery within the last year
3.3. current infectious disease
3.4. recent unhealed fractures
3.5. disorders with a highly variable course (e.g. multiple sclerosis)
3.6. falls with fracture
3.7. recurrent falls
3.8. neurologic disease
3.9. seizure disorder
3.10. Huntington’s disease
3.11. Parkinson’s disease
3.12. hepatic failure
3.13. renal failure
3.14. cerebrovascular events
3.15. class A-3 or higher (American College of Sports Medicine [ACSM] 1998).

Recruitment start date

23/06/2005

Recruitment end date

01/09/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Professor and Director
Montreal, Quebec
H3G 1Y5
Canada

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

Highfield
Southampton
SO17 1BJ
United Kingdom
+44 (0)2380 59 8672
info@rso.soton.ac.uk

Sponsor type

University/education

Website

http://www.soton.ac.uk/

Funders

Funder type

University/education

Funder name

University of Southampton (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

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

2007 results reported in conference proceedings in http://www.sciencedirect.com/science/article/pii/S0031940607600017

Publication citations

Additional files

Editorial Notes