Enhancement of Physical Fitness in Older Adults

Pain Clinical Trial

— NLC2010  

Official title:

The Effectiveness of a Trainings Program on ADL Performance, Physical Fitness, Wellbeing, and Nocturnal Cramp in Elderly People

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01421628
• Other study ID #: HanzeUnlc
• Status: Completed
• Phase: N/A
• First received: August 19, 2011
• Last updated: August 22, 2011
• Start date: September 2010
• Est. completion date: November 2010

Study information

• Verified date: December 2010
• Source: Hanze University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Physical Impairment

Intervention

Other:
• Fitness exercise program
Exercise program, daily frequency, duration of 6 weeks.

Locations

Country	Name	City	State
Netherlands	Kinese Fysiotherapeuten	Appingedam	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
Hanze University	University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical fitness	Strength, balance	six weeks	Yes
Primary	ADL performance	Performance based ADL test	six weeks	Yes
Primary	Well being	Questionnaires like SF-36	six weeks	Yes
Primary	Nocturnal cramps	Visual analogue scale (VAS)	Six weeks	Yes
Secondary	Frequency nocturnal cramp	Number of cramp attacks per day.	Six weeks	Yes