NCT00848978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2009

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

February 20, 2009

Last Update Submit

September 11, 2019

Conditions

Keywords

Functional capacityQuality of lifeDepressionFallsBody compositionPhysical activity

Outcome Measures

Primary Outcomes (1)

  • Functional capacity and quality of life

    August 2009

Secondary Outcomes (1)

  • Depressive symptoms, falls and body composition

    August 2009

Study Arms (2)

2

EXPERIMENTAL

The experimental group will participate in the aerobic and strength training program.

Behavioral: 8-week aerobic and strength training program

1

NO INTERVENTION

The usual care group will receive general physical activity guidelines.

Interventions

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.

2

Eligibility Criteria

Age90 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DepressionMotor Activity

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD Head of Department(Geriatry)

Study Record Dates

First Submitted

February 20, 2009

First Posted

February 23, 2009

Study Start

March 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

September 13, 2019

Record last verified: 2019-09

Locations