Condition category
Not Applicable
Date applied
17/06/2009
Date assigned
09/07/2009
Last edited
09/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Yngve Gustafson

ORCID ID

Contact details

Geriatric Medicine
Umeå University
Umeå
SE-901 87
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

FOPANU

Study hypothesis

1. A high-intensity functional exercise program will improve balance, gait ability, and lower-limb strength in the short- and long-term
2. An intake of protein-enriched energy supplement immediately after the exercises will increase the effect of the training
3. The high-intensity functional exercise program will reduce dependence in mobility and personal care and increase activity and will have a positive effect on depressive symptoms and psychological wellbeing, in the short- and long-term, and will increase safety and reduce falls
4. The exercise program is applicable and is perceived as positive by the participants

Ethics approval

Ethics Committee of the Medical Faculty of Umeå University approved on the 13th November 2001 (ref: 391/01)

Study design

Cluster-randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Residential care facilities

Intervention

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 challenging leg strength, postural stability, and gait ability. The physiotherapist selected exercises for each participant according to their functional deficits. All exercises were performed in weight-bearing positions, e.g., squats, turning trunk and head while standing, and walking over obstacles. The participants were encouraged by the physiotherapists to exercise with a high intensity and to increase load and difficulty progressively, considering changes in function and health status. Strength exercises were intended to be performed at 8 - 12 repetition maximum. Balance exercises were intended to challenge the participant's postural stability fully. In co-operation with a staff member, at the end of the exercise period, physical tasks were introduced with the purpose of maintaining physical function.

Control activity:
The control activity program included activities while sitting, e.g., watching films, reading, singing, and conversation. The program was based on themes, e.g., the old country shop, famous persons, and games from the past, and was expected to be interesting and stimulating for older persons including those with severe cognitive impairment.

Nutrition intervention and placebo:
The nutrition intervention consisted of a protein-enriched energy supplement. The supplement was a milk-based 200 ml drink that contained 7.4 g protein, 15.7 g carbohydrate, and 408 kJ per 100 g. The placebo drink (200 ml) contained 0.2 g protein, 10.8 g carbohydrate, and 191 kJ per 100 g. Both drinks were served in the same type of non-transparent package and had similar flavours.

Procedure:
The exercise intervention and the control activity started in March 2002, and was performed in groups of three to nine participants supervised by two physiotherapists (exercise) or one occupational therapist (control). The sessions lasted approximately 45 minutes and were held five times every two weeks for three months (13 weeks), in total on 29 occasions. The nutrition drinks were offered within five minutes after each session.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

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-perceived health, perceived balance ability and risk of falling, perceived possibility of exercise effect and attitude towards the exercise

Overall trial start date

01/01/2002

Overall trial end date

01/07/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

191

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/01/2002

Recruitment end date

01/07/2004

Locations

Countries of recruitment

Sweden

Trial participating centre

Geriatric Medicine
Umeå
SE-901 87
Sweden

Sponsor information

Organisation

Umeå University (Sweden)

Sponsor details

Geriatric Medicine
Umeå
SE-901 87
Sweden

Sponsor type

University/education

Website

http://www.umu.se/english

Funders

Funder type

Research council

Funder name

The Swedish Research Council (Sweden) (ref: K2002-27VP-14165-02B, K2002-27VX-14172-02B, K2005-27VX-15357-01A)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Vårdal Foundation (Sweden)

Alternative name(s)

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Location

Funder name

The Swedish Council for Working Life and Social Research (Sweden)

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Funder name

The Dementia Fund (Sweden)

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Funder name

The County Council of Västerbotten (Sweden)

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Location

Funder name

The Umeå University Foundation for Medical Research (Sweden)

Alternative name(s)

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Funder name

The Magnus Bergvalls Foundation (Sweden)

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Funder name

The Äldrecentrum Västerbotten (Sweden)

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Funder name

The Gun and Bertil Stohne Foundation (Sweden)

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Funder name

Erik and Anne-Marie Detlof's Foundation (Sweden)

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The Loo and Hans Ostermans Foundation (Sweden)

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Funder name

The Borgerskapet in Umeå Research Foundation (Sweden)

Alternative name(s)

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Funder name

The Ragnhild and Einar Lundström's Memorial Foundation (Sweden)

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Funder name

Norrmejerier (Sweden)

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Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2006 applicability results in http://www.ncbi.nlm.nih.gov/pubmed/16579666
2. 2006 balance, gait ability, and lower-limb strength results in http://www.ncbi.nlm.nih.gov/pubmed/16764547
3. 2008 fall results in http://www.ncbi.nlm.nih.gov/pubmed/18283231
4. 2013 UTI results in http://www.ncbi.nlm.nih.gov/pubmed/23364500
5. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23768799

Publication citations

  1. Applicability results

    Littbrand H, Rosendahl E, Lindelöf N, Lundin-Olsson L, Gustafson Y, Nyberg L, A high-intensity functional weight-bearing exercise program for older people dependent in activities of daily living and living in residential care facilities: evaluation of the applicability with focus on cognitive function., Phys Ther, 2006, 86, 4, 489-498.

  2. Fall results

    Rosendahl E, Gustafson Y, Nordin E, Lundin-Olsson L, Nyberg L, A randomized controlled trial of fall prevention by a high-intensity functional exercise program for older people living in residential care facilities., Aging Clin Exp Res, 2008, 20, 1, 67-75.

  3. UTI results

    Carlsson M, Håglin L, Rosendahl E, Gustafson Y, Poor nutritional status is associated with urinary tract infection among older people living in residential care facilities., J Nutr Health Aging, 2013, 17, 2, 186-191, doi: 10.1007/s12603-012-0087-z.

  4. Results

    Lindelöf N, Rosendahl E, Gustafsson S, Nygaard J, Gustafson Y, Nyberg L, Perceptions of participating in high-intensity functional exercise among older people dependent in activities of daily living (ADL)., Arch Gerontol Geriatr, 57, 3, 369-376, doi: 10.1016/j.archger.2013.05.003.

  5. Rosendahl E, Lindelöf N, Littbrand H, Yifter-Lindgren E, Lundin-Olsson L, Håglin L, Gustafson Y, Nyberg L, High-intensity functional exercise program and protein-enriched energy supplement for older persons dependent in activities of daily living: a randomised controlled trial., Aust J Physiother, 2006, 52, 2, 105-113.

Additional files

Editorial Notes