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A 12-week Intervention With Motivational Interviewing and Physical Activity Monitoring, to Enhance the Daily Amount of Physical Activity in Community Dwelling Older Adults - a Randomized Controlled Trial

Not Applicable
Completed
Conditions
Aging
Older Adults
Physical Activity
Interventions
Behavioral: Motivational interviews
Behavioral: Base intervention
Registration Number
NCT03906162
Lead Sponsor
University of Copenhagen
Brief Summary

To investigate if motivational-interviewing will enhance the expected effect from physical activity monitors, on physical activity in older adults, we will conduct a two-arm randomized controlled trial in 2019.

Both groups in the trial will receive a physical activity monitor for everyday use in the 12-week intervention period and a folder with information about the benefits of physical activity in older age. Participants in the intervention group will in addition to the use of the physical activity monitors receive a motivational feedback session by phone of about 20 minutes constructed from the theoretical framework of Motivational interviewing by Rollnick, Miller \& Butler and Social Cognitive Theory by Bandura. The content of the session focuses on investigating the most relevant possibilities and barriers for the participant to increase his or her levels of PA.

The primary outcome will be between group difference in average steps per day throughout the intervention period, measured objectively by the physical activity monitor (Garmin Vivofit 3). Secondary outcomes include participant reported outcome measures such as 'International Physical Activity Questionnaire', 'Nordic Physical Activity Questionnaire', 'EQ5D Quality of life questionnaire', 'UCLA Loneliness Scale', 'Self Efficacy for Exercise', and 'Outcome expectancy for Exercise'. To ensure 80% power with an alpha-level on 0.05, we will include 128 participants. The study will enroll in March 2019.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
65
Inclusion Criteria

Participants must:

  • Be minimum 70 years of age at the time of inclusion
  • Own and use an Apple/Google/Microsoft smartphone device compatible with the Garmin Connectâ„¢ Mobile application.
  • Own use an e-mail account
  • Live in Denmark and have a Danish postal address and be able to receive the intervention content.
  • Be able to walk independently with or without assistive devices.
Exclusion Criteria

Participants cannot

  • Receive active cancer treatment
  • Have major cognitive impairment (e.g. dementia or alzheimers).
  • Parkinson's or Multiple Sclerosis (or similar disease) affecting their mobility in such a way that the participants cannot walk on a daily basis.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Motivational interviewingMotivational interviewsExperimental content + base intervention
Motivational interviewingBase interventionExperimental content + base intervention
Control interventionBase interventionBase intervention
Primary Outcome Measures
NameTimeMethod
Individual intervention period average of PAM measured steps per dayA daily average of the 12 weeks of intervention

Daily step counts will be objectively measured by the PAM.

Secondary Outcome Measures
NameTimeMethod
International Physical Activity QuestionnaireBaseline + end point at 12 weeks + follow up at 6 months and 12 months

Questionnaire: The seven-item IPAQ-SF measure assesses the types of intensity of physical activity and sitting time that people has done the past seven days as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.

Nordic Physical Activity QuestionnaireBaseline + end point at 12 weeks + follow up at 6 months and 12 months

Questionnaire: It is developed to monitor compliance with the WHO recommendations on PA.

EQ5D Quality of life questionnaireBaseline + end point at 12 weeks + follow up at 6 months and 12 months

Questionnaire: The EQ-5D-5L is a generic health-related quality of life (HRQoL) measure developed as a non-disease-specific instrument for describing and valuing health states and comprises five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each of which has three levels (no problems, moderate problems and extreme problems) and a visual analogue scale (EQ VAS). The score for the five dimensions can be combined into a five-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

University of California, Los Angeles, Loneliness ScaleBaseline + end point at 12 weeks + follow up at 6 months and 12 months

Questionnaire: The 20-item UCLA loneliness scale (third version) is a self-report measure of loneliness and social isolation. The scale consists of 11 positive and nine negative items and the total score is calculated by finding the sum of 20 items (0-60), with a higher score indicating more loneliness.

Self Efficacy for ExerciseBaseline + end point at 12 weeks + follow up at 6 months and 12 months

Questionnaire: The nine-item SEE-DK addresses confidence to engage in regular exercise \[44\], when challenged by known barriers to exercise. The scale was developed initially for sedentary adults in the community who participated in an outpatient exercise program and was revised to older adults. It is designed to be administered using face-to-face interview. Response categories range from 0 (no confidence) to 10 (very confident). Item scores are used to calculate a total score (0-90), with higher scores indicating higher confidence, or self-efficacy, related to exercise. The SEE-DK is adapted to Danish older adults with acceptable face and content validity, construct validity by acceptable model fit as a unidimensional scale, and test-retest reliability.

Outcome expectancy for ExerciseBaseline + end point at 12 weeks + follow up at 6 months and 12 months

Questionnaire: The 13-item OEE-2 scale was developed from the original 9-item Outcome Expectations for Exercise scale (OEE) that specifically focused on measuring the positive outcome expectations for exercise (POEE). To complete the OEE2-DK scale the participants are asked, using a Likert scale, to strongly agree, agree, neither agree nor disagree, disagree, or strongly disagree with the stated outcomes to each statement of exercising.

Trial Locations

Locations (1)

Rasmus Tolstrup

🇩🇰

Copenhagen, Denmark

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