Condition category
Nervous System Diseases
Date applied
12/10/2012
Date assigned
23/10/2012
Last edited
29/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sulin Cheng

ORCID ID

Contact details

University of Jyvaskyla
Department of Health Sciences
PL 35
Jyvaskyla
40014
Finland
+358 40 558 0209
sulin.cheng@jyu.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TEKES 2206/31/2010

Study information

Scientific title

Effects of exercise and diet interventions on obesity-related sleep disorders: A randomized controlled trial in men

Acronym

MOTOSD

Study hypothesis

Current study hypothesis as of 25/03/2013:
1. Physical activity is beneficial in terms of good quality and proper duration of sleep. The levels of melatonin, cortisol, and neuro-active steroids are modified by physical activity and thereby influence sleep.
2. The amount of micronutrients in the diet, such as tryptophan and vitamin Bs, are correlated with quality and duration of sleep.
3. Six-month guided individualized exercise or diet counseling intervention can independently alleviate sleep disorders among adult men with sleep disorders. The improvement can be observed by changes in duration of total sleep, duration and proportion of slow-wave sleep (SWS) and rapid-eye-movement (REM) sleep, stress reactions based on heart rate variability (HRV), AHI (participants with OSA), as well as subjective sleep measures such as Epworth Sleepiness Scale score.
4. Prolonged good quality of sleep after six-month individualized exercise intervention is linked to increased oxidative stress that in turn may affect melatonin levels in the peripheral circulation because indole is rapidly used to combat free radical damage. Exercise also affects cortisol and neuro-active steroid levels. The mutual interactions between exercise and these hormone milieus are responsible for sleep-wake cycle regulation.
5. Six-month guided individualized diet counseling intervention can improve sleep quality through modification of gut microbiota composition. The composition of the gut microbial community is host specific, evolving throughout an individual’s lifetime and susceptible to both exogenous and endogenous modifications. Hence, the cross-talk between gut hormones and hypothalamic factors (gut-brain axis) is important in the regulation of food intake and sleeping disorders.

Previous study hypothesis until 25/02/2013:
1. Guided individualized exercise or diet program can independently improve the quality of sleep among men with sleep disorders. The improvement can be observed by both objective and subjective measures of quality of sleep.
2. Guided individualized exercise or diet program has significant effects on glucose and lipid metabolism as well as the composition of gut microbiota, therefore improving the quality of sleep. The cross-talk between gut hormones and hypothalamic factors (gut-brain axis) is the underlying mechanism in the regulation of food intake and sleep disorders. The re-patterning of gut microbiota composition is accompanied by optimization of body composition, which can affect the neurochemistry of sleep and thus address root causes of sleep disorders.

Please note that as of 25/02/2013, the following changes were made to the trial record:
1. The scientific title was previously "Effects of exercise and diet interventions on obesity-related sleep disorders: randomized controlled trial in men with poor quality of sleep or obstructive sleep apnoea"
2. The target number of participants was updated from 180 to 208

Please note that as of 19/06/2013, the target number of participants for this trial was updated from 208 to 330

Ethics approval

Ethics Committee of the Health Care District of Central Finland, 28 April 2011

Study design

Randomized interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

Sleep disorders, Insomnia, Obstructive sleep apnoea

Intervention

6-month exercise or diet intervention is involved in this study.

Exercise program
Based on the fitness test result an individual progressive exercise program is created according to the recommendations of ACSM (American College of Sports Medicine). This program is downloaded to a wrist computer and the subjects exercise independently following the guidance by the wrist computer. Exercise events are selected by the subject himself. The exercise is performed 3 to 5 times per week 20 to 60 minutes per time at the level of 60 to 75% of the maximum heart rate. Once a week, the subjects have the opportunity to attend supervised exercise sessions (Nordic walking, strengthening exercises, stretching, relaxation). Instructions for stretching and recovery during exercise are given to all members in exercise group. Web service (Movescount by SuuntoOy) is used to monitor the exercise adherence. Participants transfer the data on their exercise sessions from wrist computer to the service every two weeks.

Diet counseling
Specific individualized dietary programs are developed after baseline assessments on the basis of each individual’s current dietary intakes and body mass index. The diet contains energy of 40% carbohydrate with < 5 % sucrose, 40% fat (SAFA 10%, MUFA 15-20%, PUFA 10%) and 20% protein and is rich in several vitamins and micronutrients. Overweight/obese subjects are advised to moderately reduce their total energy intake (300-500 kcal per day for the first 3 months) with guidance of the proportion of macronutrients. Subjects with normal weight are advised to maintain their body weight. Furthermore, an internet service (MealTracker) is involved to provide nutritional counseling for the participants. The subjects send information about their meals by photos taken with their mobile phone camera 2-3 days a week. A nutritionist gives feedback via text messages or e-mail. In addition to information on their food intake, the subjects send regularly information on their weight online.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Current primary outcome measures as of 25/02/2013:
1.Duration and proportion of sleep stages, heart rate, heart rate variability, respiration and body movements during sleep apnea-hypopnea index [PSG for participants with OSA, Pressure sensor measurement for both OSA and other participants]
2.Subjective measures of duration and quality of sleep (Nordic sleep disorder questionnaire, Epworth Sleepiness Scale, 7-day sleep diary)
3.Lifestyle risk clusters related to sleep disorders (healthy vs. sleep disorder patients)

Previous primary outcome measures until 25/02/2013:
1. Subjective quality of sleep (sleep questionnaires including Nordic sleep questionnaire and Epworth Sleepiness Scale, 7-day sleep diary)
2. Sleep architecture, Heart rate, Heart rate variability, Respiratory and Body movements during sleep (polysomnography for subjects with sleep apnea, pressure sensors for subjects with sleep apnea and poor quality of sleep)
3. Both measurements are taken at baseline and after 6-month intervention. In addition, subjective quality of sleep is collected at 3-month.

Secondary outcome measures

Current secondary outcome measures as of 25/02/2013:
1.Anthropometry (Body weight and height; Waist, Hip, Chest and Neck circumferences)
2.Blood pressure
3.Body composition (Dual-energy x-ray absorptiometry and Bioimpedance)
4.Fitness (2 km walking test, three-minute step test)
5.Composition of the gut microbes (fecal sample)
6.Subcutaneous adipose tissue metabolism (total RNA)
7.Venous blood samples (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, glucose, insulin, histamine, tryptophan, melatonin, cortisol, adrenalin, leptin, adiponectin, neuroactive steroids, fatty acid, B vitamins, fatty acid profile, as well as inflammatory variables such as CRP, IL-6, and TNF-alpha).

Previous secondary outcome measures until 25/02/2013:
1. Venous blood samples (total cholesterol, HDL-cholesterol, triglycerides, LDL-cholesterol, apolipoproteins A-I and B, lipoprotein(a), glucose, insulin, melatonin, serotonin, cortisol, adrenin, leptin, adiponectin, fatty acid profile as well as inflammatory variables i.e., C-reactive protein, TNF and IL-6, etc.)
2. Blood pressure
3. Body composition (dual-energy x-ray absorptiometry and bioimpedance)
4. Anthropometry (body weight; waist, hip, chest and neck circumference)
5. Fitness (2 km walking test, 3 minute step test)
6. Physical activity (3 day diary)
7. Diet (3 day diary)
8. Fecal samples (composition of the gut microbes)
9. Subcutaneous adipose tissue samples (total RNA, reverse transcription reaction followed by real-time PCR with gene-specific primer sequences)
10. Measurements are taken at baseline, 3-month and after 6-month intervention

Overall trial start date

28/04/2011

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 25/02/2013:
Apnea and insomnia patient groups:
1.Men in an age range of 30 to 65 years
2.Occasionally physically active or sedentary (regular leisure-time exercise ≤ 2 times/wk& ≤ 45 min/time)
3.Reports recurrent difficulty in falling asleep, too short sleep duration or poor quality of sleep during past 2 months. Or with mild to moderate OSA (AHI 5-30 / hour), with or without continuous positive airway pressure (CPAP) treatment. If under treatment, nasal CPAP for a minimum period of 6 months prior the baseline measurements, with a minimum adherence to CPAP therapy for 4 hours per night.
4.Relatively healthy (free from cardiovascular comorbidities)

Reference (healthy men) group:
1. Men in an age range of 30 to 65 years
2.No chronic sleep disorders and medications related to sleep disorders
3.No disease and medications during past 1year
4.Relatively healthy (free from cardiovascular comorbidities)


Previous inclusion criteria until 25/02/2013:
1. Males with an age range of 30 to 65 years
2. Occasionally physically active or sedentary (regular exercise ≤ 2 times/wk& ≤ 45 min/time)
3. Reported recurrent difficulty in falling asleep, too short sleep time or poor quality of sleep during past 2 months, or diagnosed with Mild to moderate obstructive sleep apnea (AHI 5-30 / hour), with or without CPAP treatment. If under treatment, nasal CPAP for a minimum period of 6 months, with a minimum adherence to CPAP therapy for 4 hours per night.
4. Relatively healthy (free from cardiovascular comorbidities)

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

330 in total: 180 participants with sleep disorders plus 150 healthy participants

Participant exclusion criteria

Current exclusion criteria as of 25/02/2013:
1. Diseases and medications related to insulin dependent diabetes mellitus, Crohn’s disease, sarcoidosis, celiac disease, thyroid, liver and severe heart diseases, chronic diarrhea, ulcerative colitis, rheumatoid arthritis, severe osteoarthritis, systemic lupus erythematous, cancer during past 3 years.
2. Currently taking special diet (such as very low calorie diet)
3. Other diagnosed sleep disorders (such as narcolepsy)
4. Shift workers (working during night)
5. Reported cognitive impairment
6. Using antibiotics during the previous 3 months
7. History of eating disorders
8. Subjects using CPAP, professional drivers and other professions that are at risk for accident due to discontinuation in CPAP treatment
9. Not suitable for the study by a physician’s evaluation

Previous exclusion criteria until 25/02/2013:
1. Diseases and medications related to insulin dependent diabetes mellitus, Crohn’s disease, sarcoidosis, celiac disease, thyroid, liver and severe heart diseases, chronic diarrhea, ulcerative colitis, rheumatoid arthritis, severe osteoarthritis, systemic lupus erythematous, cancer during past 3 years.
2. Diet with very low calorie (VLCD)
3. Other sleep disorders e.g. narcolepsy
4. Shift workers (working during night)
5. Reported cognitive impairment
6. Using antibiotics during the previous 3 months
7. History of eating disorders
8. In patients under CPAP treatment, professional drivers and other professions that are at risk for accident due to discontinuation of CPAP treatment
9. Not suitable for the study by a physician’s evaluation

Recruitment start date

28/04/2011

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Finland

Trial participating centre

University of Jyvaskyla
Jyvaskyla
40014
Finland

Sponsor information

Organisation

Finnish Funding Agency for Technology and Innovation (TEKES)

Sponsor details

Tekes
P.O.Box 69
Kyllikinportti 2
Helsinki
00101
Finland

Sponsor type

Government

Website

http://www.tekes.fi/en/

Funders

Funder type

Government

Funder name

Finnish Funding Agency for Technology and Innovation [TEKES] (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23886347

Publication citations

  1. Protocol

    Tan X, Saarinen A, Mikkola TM, Tenhunen J, Martinmäki S, Rahikainen A, Cheng S, Eklund N, Pekkala S, Wiklund P, Munukka E, Wen X, Cong F, Wang X, Zhang Y, Tarkka I, Sun Y, Partinen M, Alen M, Cheng S, Effects of exercise and diet interventions on obesity-related sleep disorders in men: study protocol for a randomized controlled trial., Trials, 2013, 14, 235, doi: 10.1186/1745-6215-14-235.

Additional files

Editorial Notes