Lifestyle and Physical Activity as Part Of Obstructive Sleep Apnea Treatment

Summary

The goal of this clinical trial is to investigate the effects of an individually tailored lifestyle intervention on symptoms and severity of obstructive sleep apnea (OSA), physical activity (PA) levels and sedentary behavior (SB), as well as health and wellbeing in overweight participants with moderate to severe OSA treated with CPAP. Emphasis of the individually tailored SEMC-intervention (protocol of the Sports Medicine Outpatient Clinic of The Wellbeing Services County of Central Finland) is on increasing the amount of total physical activity.

The main questions the trial aims to answer are:

* Can individually tailored lifestyle intervention, in combination with CPAP therapy, alleviate the severity or symptoms of OSA in overweight participants with moderate to severe OSA?
* Does the addition of an individually tailored lifestyle intervention to CPAP therapy improve the quality of life, increase physical functioning, change body composition, and increase physical activity levels or decrease sedentary behavior of participants diagnosed with moderate to severe OSA?
* Can enhanced behavioral support (EBS), when integrated with lifestyle intervention and CPAP therapy, lead to more substantial and enduring changes in participants' levels of physical activity or sedentary behavior?

Participants will be randomized to either SEMC-intervention group, combination of SEMC-intervention and EBS, or to a control group.

In this study, it is hypothesized that participants receiving SEMC-intervention in combination with CPAP therapy will experience greater alleviation of OSA severity and symptoms, improve their quality of life, body composition and physical functioning, as well as increase physical activity levels and decrease their sedentary behavior compared to the control group. In addition, it is hypothesized that participants receiving SEMC-intervention and EBS in combination with CPAP therapy will increase their physical activity levels, and decrease their sedentary behavior to a greater extent, and these changes will be more sustained compared to merely SEMC-intervention or control group.

Conditions

• Obstructive Sleep Apnea

Interventions

BEHAVIORAL

Individually tailored lifestyle and physical activity intervention

Focus of the SEMC-protocol is on increasing PA gradually towards the national recommendations. Emphasis of counseling is on incidental exercise, endurance, and strength training. Techniques of motivational interviewing are utilized. Baseline; MD+PT counseling, medical clearance, mapping lifestyle \& life situation, goal setting, measurements, questionnaires, feedback. weeks 1-6: guided group resistance training 1hr, 1x/week. 5-10-minute warm-up, 9 exercises with weight stack equipment on large muscle groups. 2-3 sets, 12-15 repetitions. Modified individually, e.g. according to musculoskeletal problems. Emphasis on learning the basics and safety aspects. After 6 weeks unsupervised training. 3-month: MD counseling and questionnaires. 6-month: MD+PT counseling, assessing safety of PA, measurements, questionnaires, feedback. 12-month: MD+PT counseling (feedback, ensuring continuity of lifestyle changes; redirecting to municipality/NGO activities), measurements, questionnaires, feedback

BEHAVIORAL

Individually tailored lifestyle and physical activity intervention combined with enhanced behavioral support -intervention (EBS)

In addition to the SEMC-protocol, the participants will be contacted 3 times during the first 3 months (live / online as preferred). Themes: Session 1: Motivation and illness perceptions. Exploring CPAP use, PA, and SB. Session 2: Self-regulation (feedback, goal setting, self-monitoring, action planning, problem solving), activating social support, prompts/cues, and preparatory behaviors. (Included BCTs from Michie et al 2013 taxonomy: 3.2, 12.2, 8.3,) Session 3: Assessing progress and agenda setting, self-regulation, maintenance of PA. Measurements and questionnaires as with SEMC-protocol.

Sponsors & Collaborators

• University of Jyvaskyla

  collaborator OTHER

• Organisation for Respiratory Health in Finland

  collaborator UNKNOWN

• Central Finland Hospital District

  collaborator OTHER

• Filha ry

  lead OTHER

Principal Investigators

• Tuula Vasankari · Filha ry (Finnish Lung Health Association)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-18

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• Finland

Study Locations