Strength Training in Nonagenarians (STRONG)

This study is enrolling participants by invitation only.

Sponsor:

Collaborators:

Universidad Europea de Madrid

Karolinska Institutet

Information provided by:

Hospital General Universitario Gregorio Marañon

ClinicalTrials.gov Identifier:

NCT00848978

First received: February 20, 2009

Last updated: NA

Last verified: February 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	February 20, 2009
Last Updated Date	February 20, 2009
Start Date ^ICMJE	March 2009
Estimated Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 20, 2009)	Functional capacity and quality of life [ Time Frame: August 2009 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: February 20, 2009)	Depressive symptoms, falls and body composition [ Time Frame: August 2009 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Strength Training in Nonagenarians
Official Title ^ICMJE	Health Enhancing Strength Training in Nonagenarians
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Supportive Care
Condition ^ICMJE	Elderly
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: 2 The experimental group will participate in the aerobic and strength training program. Intervention: Behavioral: 8-week aerobic and strength training program No Intervention: 1 The usual care group will receive general physical activity guidelines.
Publications *	Rexach JA, Ruiz JR, Bustamante-Ara N, Villarán MH, Gil PG, Sanz Ibáñez MJ, Sanz NB, Santamaría 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Enrollment ^ICMJE	60
Estimated Completion Date	August 2009
Estimated Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	90 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT00848978
Other Study ID Numbers ^ICMJE	140
Has Data Monitoring Committee	Yes
Responsible Party	José A. Serra Rexach
Study Sponsor ^ICMJE	Hospital General Universitario Gregorio Marañon
Collaborators ^ICMJE	Universidad Europea de Madrid Karolinska Institutet
Investigators ^ICMJE	Not Provided
Information Provided By	Hospital General Universitario Gregorio Marañon
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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