ElderlySTRONGNCT00848978
Strength Training in Nonagenarians
A study testing 8-week aerobic and strength training program in people with Elderly, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 90 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly
- What is being tested?
- 8-week aerobic and strength training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2009to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 90 to 110 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Elderly
- Being tested
- 8-week aerobic and strength training program
- Keywords
- Functional capacity, Quality of life, Depression, Falls, Body composition, Physical activity
- Medical subject headings
- Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-week aerobic and strength training programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | The experimental group will participate in the aerobic and strength training program. Receives: Behavioral: 8-week aerobic and strength training program |
| 1 | No intervention | The usual care group will receive general physical activity guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity and quality of life
Measured: August 2009
Secondary outcomes (1)
Depressive symptoms, falls and body composition
Measured: August 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Europea de Madrid, Karolinska Institutet
- Responsible party
- Principal investigator, Jose Antonio Serra, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848978
- Sponsor's protocol ID
- 140
- Acronym
- STRONG
- Status last verified
- Sep 2019
- First submitted
- 20 Feb 2009
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Serra Rexach JA, Ruiz JR, Bustamante-Ara N, Villaran MH, Gil PG, Sanz Ibanez MJ, Sanz NB, Santamaria VO, Sanz NG, Prada AB, Gallardo C, Romo GR, Lucia A. Health enhancing strength training in nonagenarians (STRONG): rationale, design and methods. BMC Public Health. 2009 May 26;9:152. doi: 10.1186/1471-2458-9-152.
PubMed 19470176
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Enhancing Strength Training in Nonagenarians
- ClinicalTrials.gov ID
- NCT00848978
- Acronym / sponsor ID
- STRONG / 140
- Conditions
- Elderly
- Keywords
- Functional capacity, Quality of life, Depression, Falls, Body composition, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Collaborators
- Universidad Europea de Madrid, Karolinska Institutet
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 23 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Behavioral: 8-week aerobic and strength training programThe experimental group will participate in the aerobic and strength training program. |
| 1 | No intervention | –The usual care group will receive general physical activity guidelines. |
Who may qualify
- Ages
- 90 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 8-week aerobic and strength training programParticipants 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. | Behavioural | 2 |
Primary outcome
Functional capacity and quality of life
Time frame: August 2009
1 secondary outcome
Depressive symptoms, falls and body composition
Time frame: August 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Derived from this study: PubMed 19470176Serra Rexach JA, Ruiz JR, Bustamante-Ara N, Villaran MH, Gil PG, Sanz Ibanez MJ, Sanz NB, Santamaria VO, Sanz NG, Prada AB, Gallardo C, Romo GR, Lucia A. Health enhancing strength training in nonagenarians (STRONG): rationale, design and methods. BMC Public Health. 2009 May 26;9:152. doi: 10.1186/1471-2458-9-152.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8-week aerobic and strength training program in people with Elderly, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity and quality of life (time frame: August 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00848978, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.