NCT01421628

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable pain

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

Study Start

First participant enrolled

September 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2011

Completed
Last Updated

August 23, 2011

Status Verified

December 1, 2010

Enrollment Period

2 months

First QC Date

August 19, 2011

Last Update Submit

August 22, 2011

Conditions

PainPhysical Impairment

Keywords

older adultsexercisestretchingmobility

Outcome Measures

Primary Outcomes (4)

  • Physical fitness

    Strength, balance

    six weeks

  • ADL performance

    Performance based ADL test

    six weeks

  • Well being

    Questionnaires like SF-36

    six weeks

  • Nocturnal cramps

    Visual analogue scale (VAS)

    Six weeks

Secondary Outcomes (1)

  • Frequency nocturnal cramp

    Six weeks

Study Arms (1)

exercise

EXPERIMENTAL
Other: Fitness exercise program

Interventions

Fitness exercise programOTHER

Exercise program, daily frequency, duration of 6 weeks.

exercise

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kinese Fysiotherapeuten

Appingedam, Provincie Groningen, 9934 JD, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 22341378DERIVED

MeSH Terms

Conditions

PainMotor Activity

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Hank Hallegraeff, PT, MSc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 19, 2011

First Posted

August 23, 2011

Study Start

September 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

August 23, 2011

Record last verified: 2010-12

Locations

NL(1)