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Kuopio Fall Prevention Study. (KFPS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Eastern Finland
Information provided by (Responsible Party):
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT02665169
First received: January 11, 2016
Last updated: August 15, 2017
Last verified: June 2017
  Purpose

This study evaluates the 6 month exercise intervention (Taiji and gym course) combined with free use of communal recreation facilities in fall prevention.

Morbidity, use of social services and health outcomes of aging women in province of Kuopio, Finland are also monitored. The study combines a six months supervised exercise, followed by six months free, but unsupervised, use of recreational facilities and observational period of second year into total of 2 year follow up duration.


Condition Intervention
Accidental Falls Health Behavior Aging Behavioral: Supervised physical exercise Other: Health counselling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Fall Prevention Trial For Aging Females by Providing Supervised Exercises and Free Use of Municipal Recreation Facilities.

Resource links provided by NLM:


Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • Risk of falls [ Time Frame: Two years ]
    Method of assessment; Personal fall diary. In case of fall, subject records the event into logbook. Outcome: Number of Falls during follow up.

  • Risk of fall [ Time Frame: Two years ]
    Biweekly text message (SMS) question concerning recent falls during last 2 weeks (Reply:Yes/No). In a case of a positive reply, following phone call to the subject to validate the event. Outcome: Number of Falls during follow up.


Secondary Outcome Measures:
  • All cause morbidity [ Time Frame: two years ]
    Methods of assessment; Self reported health survey concerning chronic medical conditions. Outcome: Morbidity during follow up.

  • All cause morbidity [ Time Frame: two years ]
    Methods of assessment; Use of national health care registries and hospital discharge registries. Outcome: Validated morbidity during follow up.

  • All cause morbidity [ Time Frame: two years ]
    Methods of assessment; Hospital discharge registries. Outcome: Validated morbidity during follow up.

  • Functional capacity [ Time Frame: two years ]
    Methods of assessment; Timed Get Up and Go Test (TUG). Outcomes; Time consumed the time that a person takes to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down. Outcome: Time consumed in the task (Seconds).

  • Functional capacity [ Time Frame: two years ]
    Methods of assessment; Squatting test. Outcomes; Physical task to squat down, touch the floor with fingertips and get up, without additional support. Outcome: Able/unable to comply (Y/N).

  • Functional capacity [ Time Frame: two years ]
    Methods of assessment; One leg stand test. Outcomes; Able to maintain static one leg standing position for ten second (Seconds), Outcome: able/unable to comply (Y/N).

  • Bone mineral density [ Time Frame: two years ]
    Method of assessment; Dual X-ray Absorption (DXA) measurement in proximal femur. Outcomes; Areal bone mineral density (g/cm2).

  • Body composition [ Time Frame: two years ]
    Method of assessment; Dual X-ray Absorption (DXA) total body scan. Outcomes; body soft tissue and bone mass distribution (g).

  • Muscle strength and balance [ Time Frame: two years ]
    Methods of assessment; Maximal grip strength by using handheld dynamometer. Outcomes; Maximal muscle force produced (kg).

  • Leg muscle strength [ Time Frame: two years ]
    Methods of assessment; isometric leg extension strength in a sitting position with a force plate device. Outcomes; Maximal muscle force produced (kg).

  • Muscle strength and balance [ Time Frame: two years ]
    Methods of assessment; Balance test protocol by using force plate to measure body sway in various positions. Outcomes; velocity and distance of travel by the center of gravity (mm/second).

  • Depression [ Time Frame: two years ]
    Methods of assessment; Geriatric Depression Scale (GDS). Outcomes: Units on a Scale

  • Life satisfaction [ Time Frame: two years ]
    Methods of assessment; Life satisfaction scale (LS). Outcomes: Units on a Scale

  • Psychological stress [ Time Frame: two years ]
    Methods of assessment; Perceived Stress Scale (PSS). Outcomes: Units on a Scale.

  • Psychological stress coping [ Time Frame: two years ]
    Methods of assessment; Brief Resilience Coping Scale (BRCS). Outcomes: Units on a Scale.

  • Life satisfaction [ Time Frame: two years ]
    Methods of assessment; Life Orientation Test (LOT-R) questionnaire Outcomes: Units on a Scale.

  • health-related quality of life (HRQoL) [ Time Frame: two years ]
    Methods of assessment; 15-D self administered measure scale Outcomes: Units on a Scale.

  • Quality of life [ Time Frame: two years ]
    Methods of assessment; World Health Organization WHOQOL-BREF. Outcomes: Units on a Scale.


Other Outcome Measures:
  • Life style habits [ Time Frame: two years ]

    Self reported history of health behaviour by using OSTPRE study follow up data registry. Post hoc.

    Outcomes: Units on a scale.


  • Use of healthcare services [ Time Frame: two years ]
    Use of health service use during the follow up by utilizing hospital discharge registries. Outcome: Resources spent in healthcare during follow up(Euros)


Enrollment: 914
Study Start Date: March 2016
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise intervention group
Supervised exercise intervention of 12 months. One Taiji and one gym training per week for first six months followed by 6 months free independent use of municipal facilities, including gym, swimming hall and weight room. Written and oral health counselling provided.
Behavioral: Supervised physical exercise
Supervised physical exercises in Taiji and weight training. Free use and access into municipal recreation and training facilities for one year.
Other: Health counselling
Health counselling, fall prevention strategies at home, information concerning municipal recreational services available.
Active Comparator: Control group
Control group, without any induced exercise intervention. Written and oral health counselling provided.
Other: Health counselling
Health counselling, fall prevention strategies at home, information concerning municipal recreational services available.

Detailed Description:

In 2016, a 2-year randomized controlled trial (RCT) will be launched to investigate the effect of exercise on fall risk, injuries and subjective well-being (SWB) in aging women (n=1078) by using municipal sport services in cooperation with the city of Kuopio. The effect of the exercise intervention on functional capacity, muscle strength, bone, body composition, cognitive function, the use of health services and its cost effectiveness will also be studied.

The trial will be carried out on women belonging to the Kuopio Osteoporosis Risk Factor and Prevention (OSTPRE) Study, which is an ongoing population-based prospective cohort study, with a follow-up of 26 years. It investigates life style factors associated with fractures falls, bone mineral density and morbidity in a target population of 14 220 women, now aged between 75-84 year.

The study combines combination of a 2-year fall prevention trial with the 26 years of life style and medical data from the previous OSTPRE follow up to provide meaningful answers whether municipal exercise program can provide cost effective health gain in elderly. In addition, the study aims to answer, who will benefit from the exercise the most and what are the underlying factors explaining efficacy in the women's previous 26 years of lifestyle and medical history. The study will help to develop strategies for societal fall prevention.

  Eligibility

Ages Eligible for Study:   75 Years to 84 Years   (Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Included in the previous Osteoprosis Risk Factors and Prevention (OSTPRE) study follow up protocol, conducted in Kuopio Finland, between 1989-2015.

Exclusion Criteria:

  • Unstable angina pectoris, severe pulmonary disease, not self-ambulatory or institutionalized, moderate to severe dementia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02665169

Locations
Finland
Bone and Cartilage Research Unit, Clinical Research Centre, University of Kuopio
Kuopio, Finland, 70211
Sponsors and Collaborators
Kuopio University Hospital
University of Eastern Finland
Investigators
Principal Investigator: Heikki Kröger, Professor Department of Surgery, Kuopio University Hospital
Principal Investigator: Toni Rikkonen, Dr Kuopio Musculoskeletal Research Unit, University of Eastern Finland
  More Information

Responsible Party: Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT02665169     History of Changes
Other Study ID Numbers: KUH5203083
Study First Received: January 11, 2016
Last Updated: August 15, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Kuopio University Hospital:
Postural Balance
Cost-Benefit Analysis
Morbidity
Exercise

ClinicalTrials.gov processed this record on September 21, 2017