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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00848978
Other study ID # 140
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2009
Est. completion date September 2009

Study information

Verified date September 2019
Source Hospital General Universitario Gregorio Marañon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 90 Years to 110 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
8-week aerobic and strength training program
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.

Locations

Country Name City State
Spain Hospital General Universitario Gregorio Marañón Madrid

Sponsors (3)

Lead Sponsor Collaborator
Hospital General Universitario Gregorio Marañon Karolinska Institutet, Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional capacity and quality of life August 2009
Secondary Depressive symptoms, falls and body composition August 2009
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