Enhancement of Physical Fitness in Older Adults

Not Applicable

Completed

• Conditions: Physical Impairment; Pain
• Interventions: Other: Fitness exercise program

• Registration Number: NCT01421628
• Lead Sponsor: Hanze University of Applied Sciences Groningen

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.

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2010-12
• Study First Submitted: 2011-08-19
• Study First Submitted QC: 2011-08-22
• Last Update Submitted: 2011-08-22
• Study First Posted: 2011-08-23
• Last Update Posted: 2011-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
exercise	Fitness exercise program	-

Primary Outcome Measures

Name	Time	Method
Nocturnal cramps	Six weeks	Visual analogue scale (VAS)
Physical fitness	six weeks	Strength, balance
ADL performance	six weeks	Performance based ADL test
Well being	six weeks	Questionnaires like SF-36

Secondary Outcome Measures

Name	Time	Method
Frequency nocturnal cramp	Six weeks	Number of cramp attacks per day.

Trial Locations

Locations (1)

Kinese Fysiotherapeuten; 🇳🇱 Appingedam, Groningen, Netherlands