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The Frail Older People-Activity and Nutrition study in Umeå

The Frail Older People-Activity and Nutrition study in Umeå: a cluster-randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN31631302
Enrollment
191
Registered
2009-07-09
Start date
2002-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Residential care facilities Not Applicable

Interventions

Exercise intervention: The exercise intervention was based on the High-Intensity Functional Exercise Program (the HIFE Program). The program included functional exercises consisting of everyday tasks

Sponsors

Umeå University (Sweden)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 65 or over, either sex 2. Dependent on assistance from a person in one or more personal activities of daily living according to the Katz Index 3. Able to stand up from a chair with armrests with help from no more than one person 4. A Mini-Mental State Examination score of 10 or more 5. An approval from the resident's physician

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
1. Balance ability by Berg balance scale, at 3 (end of intervention period) and 6 months 2. Gait ability by 2.4 metre timed test, self-paced and maximum speed, at 3 and 6 months 3. Lower-limb-strength by 1 Repetition Maximum in a leg-press machine, at 3 and 6 months

Secondary

MeasureTime frame
1. Attendance, adverse events and, for the exercise group, intensity achieved, by a structured report developed for this study and completed by the supervisors after each session 2. Participants perception of participating and their perception of changes due to the activity, by a questionnaire developed for this study and for the exercise group also by an interview 3. Staff's perception of participants' changes in function by questionnaire developed for this study, at 3 months 4. Dependence in mobility and personal care by the Barthel ADL Index, at 3 and 6 months 5. Activity by the Life Space Diameter and by questions developed for this study, at 3 and 6 months 6. Falls followed-up in six months from the end of intervention period and perceived balance ability and risk of falling by questions developed for this study, at 3 and 6 months 7. Depressive symptoms and psychological wellbeing by Geriatric Depression Scale (GDS-15) and Philadelphia Geriatric Centre Morale Scale, respectively, at 3 and 6 months 8. Mobility by the Chair-stand test and the Timed up and Go, at 3 and 6 months 9. Muscle mass by bioelectric impedance and by anthropometry, at 3 and 6 months 10. Nutritional status by Mini Nutritional Assessment, body weight, and BMI, at 3 and 6 months 11. Mortality, diseases, and hospital admission, by reviewing participants' hospital records and death certificates in 2 years from the end of the intervention 12. Effect among people with dementia or with depression (compared to those without), respectively, on the primary outcome measures, ADL, and falls 13. Explanatory sub-group analyses of the effect on the primary outcomes, ADL, falls and attendance and motivation during exercise sessions. Independent variables: Barthel ADL Index, Mini-Mental State Examination, Life Space Diameter, BMI, Mini Nutritional Assessment, Berg Balance Scale, body composition by bioelectric impedance and by anthropometry, depression, dementia, previous stroke, drugs, age, sex, self-percei

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026