Clinical trial NCT01421628: Enhancement of Physical Fitness in Older Adults
Official title: The Effectiveness of a Trainings Program on ADL Performance, Physical Fitness, Wellbeing, and Nocturnal Cramp in Elderly People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Physical Impairment
Keywords: older adults
exercise
stretching
mobility
Lead sponsor: Hanze University of Applied Sciences Groningen
Sponsor class: OTHER
Collaborators: name: University Medical Center Groningen
First posted: 2011-08-23
Enrollment: 180
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Ageing is related to a decrease in physical fitness, disability and age related symptoms like nocturnal leg cramps (NLC). Our research is focused on the enhancement of physical activity and mobility to increase physical fitness and decrease disability and nocturnal cramp in older adults.

Detailed description: The ageing population leads to an increase of chronic disease and disability and to a decrease of physical activity and ADL performance. This circle can be reversed by physical exercise to increase physical fitness.

The goal of this research is to establish the effects of a trainings program on ADL performance, physical fitness and nocturnal cramps. Furthermore the characteristics from participants who benefit from the program will be investigated by the research.

The study design is a randomized intervention study. Participants are elderly people, age 65 years and older, without cognitive impairment.

Intervention: The intervention is a physical trainings program. The intensity is moderate, the frequency is daily and the total duration is 6 weeks. The control group will be provided with an education program.

Main parameters are: physical fitness, nocturnal cramp severity and frequency.

Eligibility criteria: Inclusion Criteria:

* For patients to be included in our study, they had to experience regular episodes of NLC and are in good mental health.
* The participants had to agree to the study protocol and complete the program.
* After eligibility was verified, written informed consent was obtained.

Exclusion Criteria:

* Older adults taking quinine or sleep medication and those with orthopedic problems or with severe medical problems and co morbidity, which can cause muscular spasms and/or cramps.

Primary outcomes:
measure: Physical fitness
timeFrame: six weeks
measure: ADL performance
timeFrame: six weeks
measure: Well being
timeFrame: six weeks
measure: Nocturnal cramps
timeFrame: Six weeks
Secondary outcomes:
measure: Frequency nocturnal cramp
timeFrame: Six weeks
Other outcomes:
Locations:
city: Appingedam
country: Netherlands
facility: Kinese Fysiotherapeuten
state: Groningen
Study officials:
name: Hank Hallegraeff, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hallegraeff JM, van der Schans CP, de Ruiter R, de Greef MH. Stretching before sleep reduces the frequency and severity of nocturnal leg cramps in older adults: a randomised trial. J Physiother. 2012;58(1):17-22. doi: 10.1016/S1836-9553(12)70068-1.