Condition category
Musculoskeletal Diseases
Date applied
26/01/2016
Date assigned
27/01/2016
Last edited
27/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Falls are one of the leading causes of death and injury in people over the age of 65. Studies have shown that getting more exercise can help to lower the risk of falls by improving balance, coordination and strength. Many older people find it difficult to get enough exercise, and so actively encouraging and promoting regular participation in physical activity (PA) is especially important. Being able to safely move around outside the home (mobility) is important part of long-term independence in old age. Musculoskeletal disorders (problems with the muscles and/or joints because of injury or long-term illnesses such as arthritis) are increasingly common in adults over 60. Studies have shown that when a person is hospitalized because of a musculoskeletal disorder affecting their legs and/or back, they can become very inactive during their hospital stay. This can lead to problems “getting back into” physical activity and causes mobility issues in the future. There is currently a lack of evidence about the effectiveness of combining physical activity promotion programs (to encourage people to become more active) with rehabilitative exercise training (exercises designed to help restore movement) among older adults who have been recently discharged from the hospital. The aim of this study is to find out whether a home-based physical activity promotion program can help improve the level of physical activity and mobility in older adults who are recovering from a musculoskeletal disorder affecting the legs or back.

Who can participate?
Adults over 60 years old who do not live in nursing homes and have been admitted to and discharged from hospital because of a musculoskeletal disorder affecting their legs or back.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group continue to receive their usual care, and do not take part in any extra exercise for the 6 month study period. Those in the second group also continue to receive their usual care however they also take part in the personalised home-based rehabilitation program for 6 months. This program is given by a trained physiotherapist, and involves a combination of counselling and leg exercises which get progressively harder. At the start of the study and then again after 3, 6 and 12 months, all participants have their level of physical activity measured using an accelerometer (device to measure how much they move) and complete a number of questionnaires in order to assess their mobility, independence and mental faculties.

What are the possible benefits and risks of participating?
All participants benefit from receiving information about their physical performance, and participants who receive the personalized rehabilitation program my benefit from improved mobility. There is a small risk that participants may fall or become injured during exercise.

Where is the study run from?
Palokka Health Centre and Kyllö Health Centre in Jyväskylä (Finalnd)

When is the study starting and how long is it expected to run for?
February 2016 to February 2018

Who is funding the study?
1. National Institute for Health and Welfare (Finland)
2. Social Insurance Institution of Finland (Finland)
3. Ministry of Social Affairs and Health (Finland)

Who is the main contact?
1. Professor Riku Nikander (scientific)
2. Mrs Katri Turunen (public)

Trial website

Contact information

Type

Scientific

Primary contact

Prof Riku Nikander

ORCID ID

http://orcid.org/0000-0002-2072-0510

Contact details

GeroCenter Foundation for Aging Research and Development
Rautpohjankatu 8
Jyväskylä
FI-40700
Finland

Type

Public

Additional contact

Mrs Katri Turunen

ORCID ID

http://orcid.org/0000-0001-6529-1046

Contact details

GeroCenter Foundation for Aging Research and Development
Rautpohjankatu 8
Jyväskylä
FI-40700
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Program to Promote Physical Activity and mobility recovery in older people hospitalized for musculoskeletal disorders: A single-centre randomized controlled trial

Acronym

ProPA

Study hypothesis

The 6-month individually targeted multi-component intervention will increase the level of physical activity and restores mobility of older adults compared to controls receiving standard/usual care.

Ethics approval

The Ethics Committee of the Central Finland Health Care District, 03/02/2015, ref: 3U/2014

Study design

Single-centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Condition

Musculoskeletal disorders in lower extremities or back

Intervention

Participants are randomly allocated to one of two groups.

Intervention group: Participants receive standard/usual care, as well as an individually targeted multi-component home-based program that aims to increase physical activity and restore mobility. The six-month intervention comprises goal-directed physical activity promotion (counselling and management sessions for physical activity promotion and mobility goal attainment), progressive lower extremity physical exercise program, and supported physical and social activity sessions. The intervention will start at home following hospital discharge, baseline measurements and randomization. It will be coordinated and delivered by a physiotherapist and supported by of a lay volunteer person.

Control group: Participants continue to receive standard/usual care, and are instructed to follow the instructions provided by the Health Centre-Hospital. Total duration of the intervention is six months.

Participants in both groups will be followed up for 12 months after baseline.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Level of physical activity and inactivity is objectively assessed using the accelerometer at baseline, 3 and 6 months
2. Level of physical activity is measured using validated self-reporting questionnaires at baseline, 3, 6 and 12 months
3. Mobility is assessed using the Short Physical Performance Battery and self-reporting at baseline, 3, 6 and 12 months

Secondary outcome measures

1. Life space mobility is assessed by Birmingham Life-Space Assessment (LSA) at baseline, 3, 6 and 12 months
2. Social participation and autonomy is assessed using the Impact on Participation and Autonomy (IPA) questionnaire at baseline, 6 and 12 months
3. Fear of falling assessed using the Falls Efficacy Scale International (FES) questionnaire at baseline, 3, 6 and 12 months
4. Pain is assessed using the modified Brief Pain Inventory at baseline, 3, 6 and 12 months
5. Depressive mood assessed is measured using the Centre for Epidemiologic Studies Depression Scale (CES-D) at baseline, 3, 6 and 12 months
6. Perceived barriers to indoor and outdoor physical activity is assessed using checklists for perceived environmental barriers to outdoor mobility (PENBOM; 15 items) and perceived environmental facilitators for outdoor mobility (PENFOM; 16 items) as well as self-reporting at baseline, 3, 6 and 12 months
7. Memory are assessed using Mini-Mental State Examination (MMSE) at baseline, 3, 6 and 12 months
8. Executive function is assessed using the Trail Making test at baseline, 3, 6 and 12 months
9. Use of formal and informal care is assessed through self-reporting (formal health care will be varified from the registers of Health Centre-Hosptials) at 3, 6 and 12 months
9. Hand grip strength from the dominant hand with a hand-held dynamometer at baseline, 3, 6 and 12 months

Overall trial start date

01/02/2016

Overall trial end date

28/02/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 60 years and over
2. Community-dwelling
3. Admitted and thereafter discharged to home from Health Centre-Hospital because of musculoskeletal disorder, such as orthopedic surgery of lower extremity (i.e. hip fracture, joint replacement) or some other musculoskeletal event or condition of lower extremity or back (i.e. fall, aggravated arthritis, osteoporotic fracture and/or back pain)

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

We will recruit 60 participants per group, i.e. in total 120 participants.

Participant exclusion criteria

1. Living in an institution
2. Confined to bed at time of recruitment
3. Severe memory problems (mini-mental state examination (MMSE) less than 21
4. Severe cardiovascular or pulmonary disease
5. Severe progressive disease (i.e., neoplasm, ALS, Parkinson disease).
6. Alcoholism
7. Unwillingness to participate

Recruitment start date

01/02/2016

Recruitment end date

31/10/2017

Locations

Countries of recruitment

Finland

Trial participating centre

Palokka Health Centre
Ritopohjantie 25
Jyväskylä
40270
Finland

Trial participating centre

Kyllö Health Centre
Keskussairaalantie 20
Jyväskylä
40620
Finland

Sponsor information

Organisation

GeroCenter Foundation for Aging Research and Development

Sponsor details

Rautpohjankatu 8
Jyväskylä
FI-40700 Jyväskylä
Finland

Sponsor type

Research organisation

Website

Funders

Funder type

Government

Funder name

National Institute for Health and Welfare

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Social Insurance Institution of Finland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ministry of Social Affairs and Health (for Kuopio University Hospital Catchment Area)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results will be published in peer-reviewed international scientific journals prioritizing open access series.

Intention to publish date

31/10/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes