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
  Purpose

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.


Condition Intervention
Elderly
Behavioral: 8-week aerobic and strength training program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Health Enhancing Strength Training in Nonagenarians

Resource links provided by NLM:


Further study details as provided by Hospital General Universitario Gregorio Marañon:

Primary Outcome Measures:
  • Functional capacity and quality of life [ Time Frame: August 2009 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Depressive symptoms, falls and body composition [ Time Frame: August 2009 ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: March 2009
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
The experimental group will participate in the aerobic and strength training program.
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.
No Intervention: 1
The usual care group will receive general physical activity guidelines.

  Eligibility

Ages Eligible for Study:   90 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848978

Locations
Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
Universidad Europea de Madrid
Karolinska Institutet
  More Information

No publications provided by Hospital General Universitario Gregorio Marañon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: José A. Serra Rexach
ClinicalTrials.gov Identifier: NCT00848978     History of Changes
Other Study ID Numbers: 140
Study First Received: February 20, 2009
Last Updated: February 20, 2009
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital General Universitario Gregorio Marañon:
Functional capacity
Quality of life
Depression
Falls
Body composition
Physical activity

ClinicalTrials.gov processed this record on August 28, 2014