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

February 20, 2009
February 20, 2009
March 2009
August 2009   (final data collection date for primary outcome measure)
Functional capacity and quality of life [ Time Frame: August 2009 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Depressive symptoms, falls and body composition [ Time Frame: August 2009 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Strength Training in Nonagenarians
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Elderly
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.
  • 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.
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.
 
Enrolling by invitation
60
August 2009
August 2009   (final data collection date for primary outcome measure)

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.
Both
90 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00848978
140
Yes
José A. Serra Rexach
Hospital General Universitario Gregorio Marañon
  • Universidad Europea de Madrid
  • Karolinska Institutet
Not Provided
Hospital General Universitario Gregorio Marañon
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP