ISRCTN ISRCTN38841551
DOI https://doi.org/10.1186/ISRCTN38841551
Secondary identifying numbers 3134
Submission date
24/06/2005
Registration date
28/07/2005
Last edited
13/08/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Maureen Simmonds
Scientific

Professor and Director
School of Physical and Occupational Therapy
McGill University
3654 Promenade Sir-William-Osler
Montreal, Quebec
H3G 1Y5
Canada

Phone +1 514 398 8864
Email simmondsm@uthscsa.edu

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Scientific title
Study objectives1. 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHealthy older adults
InterventionAn 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 typeOther
Primary outcome measure1. Six-Minute Walk
2. Fifty-Foot Fast Walk
Secondary outcome measures1. 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 study start date23/06/2005
Completion date01/09/2005

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants10
Key inclusion criteria1. 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
Key exclusion criteria1. 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).
Date of first enrolment23/06/2005
Date of final enrolment01/09/2005

Locations

Countries of recruitment

  • Canada
  • United Kingdom

Study participating centre

Professor and Director
Montreal, Quebec
H3G 1Y5
Canada

Sponsor information

University of Southampton (UK)
University/education

Highfield
Southampton
SO17 1BJ
England
United Kingdom

Phone +44 (0)2380 59 8672
Email info@rso.soton.ac.uk
Website http://www.soton.ac.uk/
ROR logo "ROR" https://ror.org/01ryk1543

Funders

Funder type

University/education

University of Southampton (UK)
Government organisation / Universities (academic only)
Alternative name(s)
University of Southampton UK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Abstract results results reported in conference proceedings 01/06/2007 No No