Trial Outcomes & Findings for The Effectiveness of Regular Exercise on Improving Sleep in Older Adults (NCT NCT00149747)

Results Overview

Percent of total sleep time spent in Stage 2 sleep at 12 months after adjusting for baseline level of Stage 2 sleep (i.e., baseline value included as a covariate in regression models conducted).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

66 participants

Primary outcome timeframe

baseline, 12 months

Results posted on

2016-05-24

Participant Flow

Participants recruited through radio and newspaper advertisement, direct mailings to local addresses.

Overnight pulse oximetry for 1 night to rule out sleep apnea

Participant milestones

Participant milestones
Measure	Exercise Group Regular, aerobic endurance physical activity Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity	Attention-Control (Health Education) Group Weekly general health education classes Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity
Overall Study STARTED	36	30
Overall Study COMPLETED	32	27
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Exercise Group Regular, aerobic endurance physical activity Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity	Attention-Control (Health Education) Group Weekly general health education classes Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity
Overall Study Death	1	0
Overall Study Withdrawal by Subject	3	3

Baseline Characteristics

The Effectiveness of Regular Exercise on Improving Sleep in Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exercise Group n=36 Participants Regular, aerobic endurance physical activity Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity	Attention-Control (Health Education) Group n=30 Participants Weekly general health education classes Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants	30 Participants n=7 Participants	66 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	20 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 12 months

Population: Intent to Treat

Percent of total sleep time spent in Stage 2 sleep at 12 months after adjusting for baseline level of Stage 2 sleep (i.e., baseline value included as a covariate in regression models conducted).

Outcome measures

Outcome measures
Measure	Exercise Group n=35 Participants Regular, aerobic endurance physical activity Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity	Attention-Control (Health Education) Group n=30 Participants Weekly general health education classes Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity
% Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline	53.7 percentage of sleep time Standard Deviation 9.6	51.0 percentage of sleep time Standard Deviation 9.8

SECONDARY outcome

Timeframe: 12 months

Population: Intent to treat

Self-reported sleep disturbance subscale on Pittsburgh Sleep Quality Index Subscale consists of 9 items scored on a range of 0 to 3, 0 indicating no disturbance and 3 indicating frequent disturbance. All 9 items are summed, and the summary scores is captured by 1 of 4 categories ranging from 0 to 3, with 0 indicating less frequent disturbances and 3 indicating greater frequency of disturbances.

Outcome measures

Outcome measures
Measure	Exercise Group n=35 Participants Regular, aerobic endurance physical activity Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity	Attention-Control (Health Education) Group n=30 Participants Weekly general health education classes Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity
Sleep Disturbances	1.3 units on a scale Standard Deviation .47	1.6 units on a scale Standard Deviation .5

SECONDARY outcome

Timeframe: 12 months

Peak oxygen consumption measured during symptom limited treadmill exercise stress test

Outcome measures

Outcome measures
Measure	Exercise Group n=35 Participants Regular, aerobic endurance physical activity Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity	Attention-Control (Health Education) Group n=30 Participants Weekly general health education classes Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity
Peak Exercise Oxygen Consumption	24.7 mL of 02 per Kg per minute Standard Deviation 2.2	23.1 mL of 02 per Kg per minute Standard Deviation 2.3

Adverse Events

Exercise Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Attention-Control (Health Education) Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Abby C. King

Stanford Prevention Research Center

Phone: 6507252826

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place