Community-based Complex Intervention to Prevent Loss of Physical Function and Disability in Home-dwelling Older Adults

NCT04531852 | Completed DMC

• 1 other identifier: INTERREG 5a Number: 38-1.0-16
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of this study is to compare the effect of 12 weeks group-based exercise program enhanced with 24 weeks health empowerment program (HEP) to an extended usual care condition (the HEP program alone) on physical function, disability, health-related quality of life (HQoL) in home-dwelling older adults at risk for disability. Interventions were implemented into existing health care pathways and added to routine preventive programs using a two-armed randomized intervention design with multiple sites.

Conditions

Disability Physical

Keywords

Low physical function; Functional performance; Disability; Implementation; complex intervention; Primary sector; Exercise; Resistance training; Aged; Int. Classif. of Functioning, Disability and Health (ICF); Primary prevention; Secondary prevention; Self-management; Health behaviour; Health risk behaviour; Motivation; Self-efficacy; Empowerment

Outcome Measures

Primary Outcomes (1)

• Change in physical function

  Physical function was assessed by the Short Physical Performance Battery (SPPB). The SPPB consists of three objective physical function tests: balance, gait and chair-rise. Sub-scores: Balance test, range 0-4 points: 1. Feet in parallel position (0-9.99 sec = 0 point; ≥10 sec = 1 point) Unable: 0 points: balance test stops 2. Feet in semi-tandem position (0-9.99 sec = 0 point; ≥10 sec = +1 point) Unable: balance test stops 3. Feet in tandem position (3 to 9.99 sec = +1 point, ≥10 sec = +2 point) Gait test, range 0-4 points: Time to walk 3 meters in normal pace * \<3.62 (4 points) * 3.62 to 4.65 seconds (3 points) * 4.66 to 6.52 seconds (2 points) * \>6.52 seconds (1 point) * Unable (0 points) Chair stand test: 5 repetitions from seated to standing position with arms across chest. * ≤11.19 seconds (4 points) * 11.20 to 13.69 seconds (3 points) * 13.70 to 16.69 seconds (2 points) * 16.70 seconds (1 point) * Unable (0 points) The composite SPPB score ranges from

  The SPPB is assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase)

Secondary Outcomes (8)

• Change in self-reported physical function and disability

  Assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase)

• Change in health related quality of life

  Assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase)

• Change in self-efficacy for exercise Exercise

  Assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase)

• Change in outcome expectations for Exercise

  Assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase)

• Change in perceived barriers for exercise

  Assessed at week 12 (after the intensive phase) and week 24 (after the maintenance phase)

Other Outcomes (14)

• Subject age (descriptive)

  Assessed at week 0 (baseline)

• Sex (descriptive)

  Assessed at week 0 (baseline)

• Living conditions (descriptive)

  Assessed at week 0 (baseline)

Study Arms (1)

At risk older adults

Home-dwelling older adults entitled to preventive home visit, who had a risk profile for loss of physical function and disability identified through a multi-domain screening instrument

Other: CALSTI - Complex Active Lifestyle Intervention; Behavioral: SEMAI - Self-Management Intervention

Interventions

CALSTI - Complex Active Lifestyle Intervention OTHER

A group-based exercise (EX) and health empowerment program (HEP) conducted in the local area. Structured, progressive resistance (55-60%), balance (10-15%), endurance (10-15%) exercise was delivered twice weekly for 12 weeks under supervision of a trained instructor. HEP consists of 8 group sessions aiming to facilitate long-term behaviour change, by empowering older citizens to act on current risk behaviours (i.e. low physical activity/exercise, high sedentary behaviour, social isolation, poor dietary habits, incontinence). Four sessions were conducted during the exercise intervention period (phase 1 - intensive), and four sessions in the following 12 weeks (phase 2 - maintenance).

Also known as: EXERCISE your shape, [DK: TRÆN din form], [DE: TRAINIERE Deine Form]

At risk older adults

SEMAI - Self-Management Intervention BEHAVIORAL

A low-cost enhancement of the existing preventive service where citizens are information about relevant health resources. Citizens allocated to SEMAI intervention are offered the health-empowerment program as outlined above, including four extra sessions dedicated to practical experiences with exercising. 24 weeks duration in total, with eight sessions in phase 1 and four sessions in phase 2

Also known as: SHAPE your life, [DK: FORM dit liv], [DE: FORME Dein Leben]

At risk older adults

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Home-dwelling older adults entitled to a yearly preventive home-visit according to the Danish social act, living in three provincial municipalities in Denmark (Odense, Slagelse and Esbjerg)

You may qualify if:

• Subjects were eligible if at least one of following criteria was met:
• Reduced physical function: SPPB score ≤9
• Fatigability: Pittsburg Fatigability score of 15 or above (≥15)\*
• Low physical activity: Physically active ≤1day per week while sitting ≥8 hours on a normal day
• Falls: ≥2 fall over the past year
• Have pain: Brief Pain Inventory interference score ≥20

You may not qualify if:

• High functioning (Composite SPPB score \>10)
• Too physically active (Physically active ≥3 days/week while sitting down \<5 hours during a normal day)
• Deadly or critical illness (Cancer, severe heart failure)
• Recent surgery that is expected to affect the intensity of exercise and limit activity#
• Recent fractures that is expected to affect the intensity of exercise and limit activity#
• Chronic pain that prevents regular exercise
• Reduced cognitive function (Dementia, Alzheimer's)
• If the subject has completed a rehabilitation process in relation with an operation or fracture, the citizen is free to attend.
• Additional precautions:
• Indication of reduced cognitive function: When Six-Item Cognitive Impairment Screener score \<4, subjects are referred to experts for further assessment and determination of cognitive function.
• When unintended weight loss and underweight is detected by the nutritional assessment scheme (score =2), citizens are referred to medical doctor or dietician to recover this, prior to being enrolled in the study.

Sponsors & Collaborators

• University of Southern Denmark: lead
• Esbjerg Municipality: collaborator
• Municipality of Slagelse: collaborator
• Municipality of Odense: collaborator
• Christian Albrechts Universität zu Kiel: collaborator
• Europa Universität Flensburg: collaborator
• AOK Nordwest: collaborator
• Howe Fiedler Stiftung Kiel: collaborator
• Arla Foods - Denmark: collaborator

Study Sites (3)

Municipality of Esbjerg, Health & Care - Project & Development [Esbjerg Kommune - Sundhed & Omsorg - Projekt & Udvikling]

Esbjerg, Southern Denmark, 6700, Denmark

Location

Municipality of Odense [Odense Kommune]

Odense, Southern Denmark, Odense SV, Denmark

Location

Municipality of Slagelse [Slagelse Kommune]

Slagelse, Southern Denmark, 4200, Denmark

Location

Related Publications (1)

• Svensson NH, Thorlund JB, Ollgaard Olsen P, Sondergaard J, Wehberg S, Andersen HS, Caserotti P, Thilsing T. Effect of exercise referral schemes and self-management strategies on healthcare service utilisation among community-dwelling older adults: secondary analyses of two randomised controlled trials. BMJ Open. 2024 Nov 2;14(11):e084938. doi: 10.1136/bmjopen-2024-084938.

  PMID: 39488430 DERIVED

Related Links

• The Welfare Innovation in Primary Prevention project (WIPP) official homepage

MeSH Terms

Conditions

Motor Activity; Empowerment

Condition Hierarchy (Ancestors)

Behavior; Social Behavior

Study Officials

• Paolo Caserotti, PhD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 31, 2020
• Study Start: June 22, 2017
• Primary Completion: November 29, 2019
• Study Completion: December 22, 2019
• Last Updated: August 18, 2021

Record last verified: 2020-07

Locations

DK (3)