- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00848978
Strength Training in Nonagenarians (STRONG)
September 11, 2019 updated by: Jose Antonio Serra, Hospital General Universitario Gregorio Marañon
Health Enhancing Strength Training in Nonagenarians
The Health Enhancing Strength Training in Nonagenarians (STRONG) is a randomised control trial to assess the effectiveness of an aerobic and strength training program for improving functional capacity and quality of life in nonagenarians.
Sixty (51 women) nonagenarians (age range: 90-102 years) who live in a geriatric nursing home will be randomly assigned to either a usual care (control) group (n=30) or an intervention (training) group (n=30).
Participants allocated in the usual care group will receive general physical activity guidelines and participants allocated in the intervention group will also enroll in three weekly non-consecutive individualized training sessions (~45-50 min each) during 8 weeks.
The exercise program will consist of muscular strength [with a special focus on leg press at 30% (start of the program) to 70% 1 repetition maximum (end)] and aerobic exercises (cycle-ergometry during 3-5 to 15 minutes at 12-14 points in the rate of perceived exertion scale).
Results from STRONG will help to better understand the potential of regular physical activity for improving the well-being of the oldest population groups.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Madrid, Spain, 28007
- Hospital General Universitario Gregorio Marañón
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
90 years to 110 years (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age: 90 years or over.
- Planning to stay in the same nursing home during the study.
- Able to ambulate, with or without assistance.
- Able to communicate.
- Informed consent: Must be capable and willing to provide consent.
Exclusion Criteria:
- Acute or terminal illness.
- Myocardial infarction in the past 3 months.
- Not capable to ambulate.
- Unstable cardiovascular disease or other medical condition.
- Upper or lower extremity fracture in the past 3 months.
- Severe dementia.
- Unwillingness to either complete the study requirements or to be randomised into control or training group.
- Presence of neuromuscular disease or drugs affecting neuromuscular function.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 2
The experimental group will participate in the aerobic and strength training program.
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Participants allocated in the intervention group will be enrolled in three weekly non-consecutive training sessions for 8 weeks.
Each session will last for about 45-50 min.
The exercise program will consist of muscular strength and aerobic exercises.
Each session will start and end with a low intensity ~5-7 min warm-up and cool-down period respectively, consisting mainly of stretching exercises involving all major muscle groups.
|
NO_INTERVENTION: 1
The usual care group will receive general physical activity guidelines.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Functional capacity and quality of life
Time Frame: August 2009
|
August 2009
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Depressive symptoms, falls and body composition
Time Frame: August 2009
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August 2009
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (ACTUAL)
September 1, 2009
Study Completion (ACTUAL)
September 1, 2009
Study Registration Dates
First Submitted
February 20, 2009
First Submitted That Met QC Criteria
February 20, 2009
First Posted (ESTIMATE)
February 23, 2009
Study Record Updates
Last Update Posted (ACTUAL)
September 13, 2019
Last Update Submitted That Met QC Criteria
September 11, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 140
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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