This trial is active, not recruiting.

Conditions fragility, physical disability
Treatments physical exercise intervention, lifestyle counseling
Phase phase 2
Sponsor Hanze University
Collaborator University Medical Centre Groningen
Start date October 2009
End date December 2012
Trial size 164 participants
Trial identifier NCT01646632, ABR NL 24558.042.09


Questions: Does an evidence-based exercise program increase activities of daily living and physical fitness in institutionalized older adults? Does this program decrease the care dependency of institutionalized older adults? Design: A randomized control trial using group-based exercise was performed in 14 assisted-living facilities for the elderly (>70 years old).

Outcome measures: Outcome measures were performance on ADL, physical fitness, and care dependency measures. The exercise program comprised group-based progressive resistance training, balance training, and functional training. The control intervention comprised social group meetings.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Progressive resistance training, balance training, functional training
physical exercise intervention strength training
the experimental intervention included group- based progressive resistance training, balance training, and functional training, two times a week, one hour sessions, lasting 16 weeks.
(Placebo Comparator)
Recreational sessions
lifestyle counseling leisure time activities without physical activity
the control intervention included recreational sessions, including talks, video's, music, board games etc. No physical activity was involved in the control intervention.

Primary Outcomes

ADL performance in institutionalized elderly people
time frame: 16 weeks

Secondary Outcomes

Physical fitness in institutionalized older people
time frame: 16 weeks
Care dependency in institutionalized older people
time frame: 16 weeks

Eligibility Criteria

Male or female participants at least 70 years old.

Inclusion Criteria: - Age 70 and older - Being able to walk at least 10 meters - Not cognitive impaired Exclusion Criteria: - Dementia - Severe hart failure - Progressive neurological diseases

Additional Information

Official title Effects of Exercise on ADL Performance, Physical Fitness, and Care Dependency in Institutionalized Elderly People
Description To improve physical fitness, a combined exercise program including progressive resistance training, balance training, and functional training will be used in a sample of institutionalized elderly people. The exercise program has a frequency of 2 times a week and a duration of 16 weeks. The intensity is moderate, measured on a 0-10 scale. The level of intensity is specified as follows: on a 10- point scale, where no movement is 0 and maximal effort of a muscle group is 10, moderate-intensity effort is a 5 or 6, and high- intensity effort is a 7 or 8. There is currently insufficient evidence that a combined exercise program, developed to improve physical fitness, can improve ADL performance and care dependency also.
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by Hanze University.