Clinical trial NCT00848978: Strength Training in Nonagenarians
Official title: Health Enhancing Strength Training in Nonagenarians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Keywords: Functional capacity
Quality of life
Depression
Falls
Body composition
Physical activity
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
Collaborators: name: Universidad Europea de Madrid
name: Karolinska Institutet
First posted: 2009-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 90
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Functional capacity and quality of life
timeFrame: August 2009
Secondary outcomes:
measure: Depressive symptoms, falls and body composition
timeFrame: August 2009
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
Study officials:
References:
citation: 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.