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Strength Training in Nonagenarians (STRONG)

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ClinicalTrials.gov Identifier: NCT00848978
Recruitment Status : Completed
First Posted : February 23, 2009
Last Update Posted : September 13, 2019
Sponsor:
Collaborators:
Universidad Europea de Madrid
Karolinska Institutet
Information provided by (Responsible Party):
Jose Antonio Serra, Hospital General Universitario Gregorio Marañon

Tracking Information
First Submitted Date  ICMJE February 20, 2009
First Posted Date  ICMJE February 23, 2009
Last Update Posted Date September 13, 2019
Study Start Date  ICMJE March 2009
Actual Primary Completion Date September 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00848978 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2009)
Depressive symptoms, falls and body composition [ Time Frame: August 2009 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 Arms  ICMJE
  • 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 * Serra 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. doi: 10.1186/1471-2458-9-152.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2009)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 90 Years to 110 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00848978
Other Study ID Numbers  ICMJE 140
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jose Antonio Serra, Hospital General Universitario Gregorio Marañon
Study Sponsor  ICMJE Hospital General Universitario Gregorio Marañon
Collaborators  ICMJE
  • Universidad Europea de Madrid
  • Karolinska Institutet
Investigators  ICMJE Not Provided
PRS Account Hospital General Universitario Gregorio Marañon
Verification Date September 2019

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